Epimed I N T Inc

FDA Filings

This page includes the latest FDA filings for Epimed I N T Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Epimed I N T Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• MINTA MEDICAL LIMITED

FDA Registration(s)

• Registration Number: 1316297
• FEI Number: 1316297
• Name: EPIMED INTERNATIONAL, INC.
• Owner & Operator: Epimed International, Inc.
• Contact Address: 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK; Johnstown NY 12095 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK; JOHNSTOWN, NY 12095 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 1643059
• FEI Number: 1643059
• Name: Epimed International, Inc.
• Owner & Operator: Epimed International, Inc.
• Contact Address: 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK; Johnstown NY 12095 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 13958 Diplomat Drive ; Farmers Branch, TX 75234 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10818788023688 EPIMED INTERNATIONAL, INC	Epimed 107-1618	2023-11-29
GUDID 10818788023671 EPIMED INTERNATIONAL, INC	Epimed 107-1616	2023-11-29
GUDID 10818788022087 EPIMED INTERNATIONAL, INC	Epimed 109-1613	2023-11-29
GUDID 10818788022070 EPIMED INTERNATIONAL, INC	Epimed 109-1413	2023-11-29
GUDID 10818788023695 EPIMED INTERNATIONAL, INC	Epimed International, Inc. 138-1427	2022-05-13
GUDID 10818788021509 EPIMED INTERNATIONAL, INC	Epimed International, Inc. 197-3522	2022-05-13
GUDID 10818788021486 EPIMED INTERNATIONAL, INC	Epimed International, Inc. 197-3520	2022-05-13
GUDID 10818788021431 EPIMED INTERNATIONAL, INC	Epimed International, Inc. 233-2005	2022-04-20
GUDID 10818788020540 EPIMED INTERNATIONAL, INC	Epimed International, Inc. 197-3518	2022-04-20
GUDID 10818788020410 EPIMED INTERNATIONAL, INC	Epimed International, Inc. 268-2010	2022-04-13
GUDID 10818788023626 EPIMED INTERNATIONAL, INC	Epimed 119-2080	2021-06-25
GUDID 10818788023619 EPIMED INTERNATIONAL, INC	Epimed 231-1615	2021-06-25
GUDID 10818788023602 EPIMED INTERNATIONAL, INC	Epimed 233-1615	2021-06-25
GUDID 10818788023596 EPIMED INTERNATIONAL, INC	Epimed 125-1820T	2021-06-25
GUDID 10818788023527 EPIMED INTERNATIONAL, INC	Epimed 108-1516	2020-11-06
GUDID 10818788023510 EPIMED INTERNATIONAL, INC	Epimed 108-1418	2020-11-06
GUDID 10818788023503 EPIMED INTERNATIONAL, INC	Epimed 108-1416	2020-11-06
GUDID 10818788023497 EPIMED INTERNATIONAL, INC	Epimed 108-1415	2020-11-06
GUDID 10818788023480 EPIMED INTERNATIONAL, INC	Epimed 301-1815	2020-09-03
GUDID 10818788023473 EPIMED INTERNATIONAL, INC	Epimed 301-1615	2020-09-03
GUDID 10818788022698 EPIMED INTERNATIONAL, INC	Epimed 300-1815	2020-09-03
GUDID 10818788022681 EPIMED INTERNATIONAL, INC	Epimed 300-1615	2020-09-03
GUDID 10818788023466 EPIMED INTERNATIONAL, INC	Epimed 131-2545	2020-07-31
GUDID 10818788023459 EPIMED INTERNATIONAL, INC	Epimed 131-2535	2020-07-31
GUDID 10818788023442 EPIMED INTERNATIONAL, INC	Epimed 131-2260	2020-07-31
GUDID 10818788023435 EPIMED INTERNATIONAL, INC	Epimed 131-2245	2020-07-31
GUDID 10818788023428 EPIMED INTERNATIONAL, INC	Epimed 131-2235	2020-07-31
GUDID 10818788023411 EPIMED INTERNATIONAL, INC	Epimed 131-2225	2020-07-31
GUDID 10818788023404 EPIMED INTERNATIONAL, INC	Epimed 131-2060	2020-07-31
GUDID 10818788023398 EPIMED INTERNATIONAL, INC	Epimed 126-2235	2020-07-31
GUDID 10818788023381 EPIMED INTERNATIONAL, INC	Epimed 126-2225	2020-07-31
GUDID 10818788023374 EPIMED INTERNATIONAL, INC	Epimed 126-2060	2020-07-31
GUDID 10818788023367 EPIMED INTERNATIONAL, INC	Epimed 126-2045	2020-07-31
GUDID 10818788023350 EPIMED INTERNATIONAL, INC	Epimed 126-2035	2020-07-31
GUDID 10818788023343 EPIMED INTERNATIONAL, INC	Epimed 126-2025	2020-07-31
GUDID 10818788023336 EPIMED INTERNATIONAL, INC	Epimed 126-1860	2020-07-31
GUDID 10818788023329 EPIMED INTERNATIONAL, INC	Epimed 126-1845	2020-07-31
GUDID 10818788023312 EPIMED INTERNATIONAL, INC	Epimed 126-1835	2020-07-31
GUDID 10818788023305 EPIMED INTERNATIONAL, INC	Epimed 126-1825	2020-07-31
GUDID 10818788023299 EPIMED INTERNATIONAL, INC	Epimed 126-1760	2020-07-31
GUDID 10818788023282 EPIMED INTERNATIONAL, INC	Epimed 126-1735	2020-07-31
GUDID 10818788023275 EPIMED INTERNATIONAL, INC	Epimed 126-1635	2020-07-31
GUDID 10818788023268 EPIMED INTERNATIONAL, INC	Epimed 257-2015	2020-06-12
GUDID 10818788023251 EPIMED INTERNATIONAL, INC	Epimed 257-1815	2020-06-12
GUDID 10818788023244 EPIMED INTERNATIONAL, INC	Epimed 257-1615	2020-06-12
GUDID 10818788023237 EPIMED INTERNATIONAL, INC	Epimed 257-1610	2020-06-12
GUDID 10818788023220 EPIMED INTERNATIONAL, INC	Epimed 256-2205	2020-06-12
GUDID 10818788023213 EPIMED INTERNATIONAL, INC	Epimed 220-2010	2020-06-12
GUDID 10818788023206 EPIMED INTERNATIONAL, INC	Epimed 220-1810	2020-06-12
GUDID 10818788023183 EPIMED INTERNATIONAL, INC	Epimed 233-1610	2020-06-12
GUDID 10818788023176 EPIMED INTERNATIONAL, INC	Epimed 233-1810	2020-06-12
GUDID 10818788023169 EPIMED INTERNATIONAL, INC	Epimed 233-2010	2020-06-12
GUDID 10818788023152 EPIMED INTERNATIONAL, INC	Epimed 231-1610	2020-06-12
GUDID 10818788023145 EPIMED INTERNATIONAL, INC	Epimed 231-2010	2020-06-12
GUDID 10818788023138 EPIMED INTERNATIONAL, INC	Epimed 231-1810	2020-06-12
GUDID 10818788023121 EPIMED INTERNATIONAL, INC	Epimed 243-1810	2020-06-12
GUDID 10818788023114 EPIMED INTERNATIONAL, INC	Epimed 243-1610	2020-06-12
GUDID 10818788023107 EPIMED INTERNATIONAL, INC	Epimed 241-1810	2020-06-12
GUDID 10818788023091 EPIMED INTERNATIONAL, INC	Epimed 241-1610	2020-06-12
GUDID 10818788023084 EPIMED INTERNATIONAL, INC	Epimed 251-2010	2020-06-12
PMN K190256 | GXI Epimed International, Inc.	RULO? Radiofrequency Lesion Probe	2019-09-09
PMN K190256 | GXI EPIMED INTERNATIONAL, INC.	RULO? Radiofrequency Lesion Probe	2019-09-09
GUDID 10818788021523 EPIMED INTERNATIONAL, INC	Epimed 191-950	2019-08-09
GUDID 10818788021516 EPIMED INTERNATIONAL, INC	Epimed 191-750	2019-08-09
GUDID 10818788021691 EPIMED INTERNATIONAL, INC	Epimed 199-2340	2019-07-22
GUDID 10818788021479 EPIMED INTERNATIONAL, INC	Epimed 189-2340	2019-07-22
GUDID 10818788021462 EPIMED INTERNATIONAL, INC	Epimed 189-2260	2019-07-22
GUDID 10818788021455 EPIMED INTERNATIONAL, INC	Epimed 188-2340	2019-07-22
GUDID 10818788021448 EPIMED INTERNATIONAL, INC	Epimed 188-2260	2019-07-22
GUDID 00818788022554 EPIMED INTERNATIONAL, INC	Epimed 286-2015	2019-07-03
GUDID 00818788021847 EPIMED INTERNATIONAL, INC	Epimed 262-2015	2019-07-03
GUDID 00818788021830 EPIMED INTERNATIONAL, INC	Epimed 262-2010	2019-07-03
GUDID 00818788021793 EPIMED INTERNATIONAL, INC	Epimed 261-2015	2019-07-03
GUDID 00818788021786 EPIMED INTERNATIONAL, INC	Epimed 261-2010	2019-07-03
GUDID 10818788022650 EPIMED INTERNATIONAL, INC	Epimed 287-2210	2019-04-01
GUDID 10818788022643 EPIMED INTERNATIONAL, INC	Epimed 287-2015	2019-04-01
GUDID 10818788022636 EPIMED INTERNATIONAL, INC	Epimed 287-2010	2019-04-01
GUDID 10818788022629 EPIMED INTERNATIONAL, INC	Epimed 287-1815	2019-04-01
GUDID 10818788022612 EPIMED INTERNATIONAL, INC	Epimed 287-1810	2019-04-01
GUDID 10818788022605 EPIMED INTERNATIONAL, INC	Epimed 287-1615	2019-04-01
GUDID 10818788022599 EPIMED INTERNATIONAL, INC	Epimed 287-1610	2019-04-01
GUDID 10818788022575 EPIMED INTERNATIONAL, INC	Epimed 286-2210	2019-04-01
GUDID 10818788022568 EPIMED INTERNATIONAL, INC	Epimed 286-2205	2019-04-01
GUDID 10818788022544 EPIMED INTERNATIONAL, INC	Epimed 286-2010	2019-04-01
GUDID 10818788022513 EPIMED INTERNATIONAL, INC	Epimed 282-2210	2019-04-01
GUDID 10818788022506 EPIMED INTERNATIONAL, INC	Epimed 282-2015	2019-04-01
GUDID 10818788022490 EPIMED INTERNATIONAL, INC	Epimed 282-2010	2019-04-01
GUDID 10818788022483 EPIMED INTERNATIONAL, INC	Epimed 282-1815	2019-04-01
GUDID 10818788022476 EPIMED INTERNATIONAL, INC	Epimed 282-1810	2019-04-01
GUDID 10818788022452 EPIMED INTERNATIONAL, INC	Epimed 281-2210	2019-04-01
GUDID 10818788022445 EPIMED INTERNATIONAL, INC	Epimed 281-2205	2019-04-01
GUDID 10818788022438 EPIMED INTERNATIONAL, INC	Epimed 281-2015	2019-04-01
GUDID 10818788022421 EPIMED INTERNATIONAL, INC	Epimed 281-2010	2019-04-01
GUDID 10818788022124 EPIMED INTERNATIONAL, INC	Epimed 257-2010	2019-04-01
GUDID 10818788022025 EPIMED INTERNATIONAL, INC	Epimed 267-2015	2019-04-01
GUDID 10818788022018 EPIMED INTERNATIONAL, INC	Epimed 267-2010	2019-04-01
GUDID 10818788021981 EPIMED INTERNATIONAL, INC	Epimed 266-2015	2019-04-01
GUDID 10818788021967 EPIMED INTERNATIONAL, INC	Epimed 266-2010	2019-04-01
GUDID 10818788021493 EPIMED INTERNATIONAL, INC	Epimed 257-1810	2019-04-01
PMN K190256 Epimed International, Inc.	Rulo Radiofrequency Lesion Probe	2019-03-08
GUDID 10818788021011 EPIMED INTERNATIONAL, INC	Epimed 154-1912	2019-02-07
GUDID 10818788020779 EPIMED INTERNATIONAL, INC	Epimed 158-2114	2019-02-07
GUDID 10818788020526 EPIMED INTERNATIONAL, INC	Epimed 181-2540	2019-02-07
PMN K133316 | BSO Epimed International, Inc.	Spirol Block Catheter	2014-12-29
PMN K133316 | BSO EPIMED INTERNATIONAL, INC.	Spirol Block Catheter	2014-12-29
PMN K133316 EPIMED INTERNATIONAL, INC.	SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)	2014-05-28
MAB EPIMED INTERNATIONAL, INC.	Vein Graft Ring Markers	2014-01-21
MAB EPIMED INTERNATIONAL, INC.	Heart Rings	2014-01-21
HNL EPIMED INTERNATIONAL, INC.	Lacrimal Eye Probe	2014-01-20
PMN K854334 | GXH Epimed International, Inc.	PainBlocker	2013-04-24
PMN K854334 | GXH EPIMED INTERNATIONAL, INC.	PainBlocker	2013-04-24
PMN K981329 | BSO Epimed International, Inc.	Spirol Epidural Catheter	2008-04-16
PMN K981329 | BSO EPIMED INTERNATIONAL, INC.	Spirol Epidural Catheter	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Tun-L-XL	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Tun-L-Kath	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Racz Epidural Catheter	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Feth-R-Kath	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	E-Kath	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Brevi-XL	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Brevi-Kath	2008-04-16
PMN K954584 | BSO Epimed International, Inc.	Brevi STF	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Tun-L-XL	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Tun-L-Kath	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Racz Epidural Catheter	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Feth-R-Kath	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	E-Kath	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Brevi-XL	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Brevi-Kath	2008-04-16
PMN K954584 | BSO EPIMED INTERNATIONAL, INC.	Brevi STF	2008-04-16
PMN K072005 | BSP Epimed International, Inc.	RK Epidural Introducer Needle	2008-04-16
PMN K072005 | BSP EPIMED INTERNATIONAL, INC.	RK Epidural Introducer Needle	2008-04-16
PMN K053318 | BSP Epimed International, Inc.	RX Epidural Needle	2008-04-16
PMN K053318 | BSP EPIMED INTERNATIONAL, INC.	RX Epidural Needle	2008-04-16
PMN K051860 | MIA Epimed International, Inc.	Peelaway Introducer Needle	2008-04-16
PMN K051860 | MIA Epimed International, Inc.	Flexible Introducer Cannula	2008-04-16
PMN K051860 | MIA Epimed International, Inc.	Blunt Access Cannula	2008-04-16
PMN K051860 | MIA EPIMED INTERNATIONAL, INC.	Peelaway Introducer Needle	2008-04-16
PMN K051860 | MIA EPIMED INTERNATIONAL, INC.	Flexible Introducer Cannula	2008-04-16
PMN K051860 | MIA EPIMED INTERNATIONAL, INC.	Blunt Access Cannula	2008-04-16
PMN K051171 | CAZ Epimed International, Inc.	Stingray Epidural Cath. Connector	2008-04-16
PMN K051171 | CAZ Epimed International, Inc.	Nexus Catheter Connector	2008-04-16
PMN K051171 | CAZ EPIMED INTERNATIONAL, INC.	Stingray Epidural Cath. Connector	2008-04-16
PMN K051171 | CAZ EPIMED INTERNATIONAL, INC.	Nexus Catheter Connector	2008-04-16
PMN K043467 | BSP Epimed International, Inc.	Wiley Spinal	2008-04-16
PMN K043467 | BSP EPIMED INTERNATIONAL, INC.	Wiley Spinal	2008-04-16
PMN K041843 | BSP Epimed International, Inc.	Day Needle	2008-04-16
PMN K041843 | BSP Epimed International, Inc.	Blunt Nerve Block Needle	2008-04-16
PMN K041843 | BSP EPIMED INTERNATIONAL, INC.	Day Needle	2008-04-16
PMN K041843 | BSP EPIMED INTERNATIONAL, INC.	Blunt Nerve Block Needle	2008-04-16
PMN K041021 | GXI Epimed International, Inc.	R-F Cannula	2008-04-16
PMN K041021 | GXI EPIMED INTERNATIONAL, INC.	R-F Cannula	2008-04-16
PMN K041021 | GXD Epimed International, Inc.	R-F Cannula	2008-04-16
PMN K041021 | GXD EPIMED INTERNATIONAL, INC.	R-F Cannula	2008-04-16
PMN K030562 | BSP Epimed International, Inc.	Tuohy Epidural Needle	2008-04-16
PMN K030562 | BSP EPIMED INTERNATIONAL, INC.	Tuohy Epidural Needle	2008-04-16
PMN K023140 | BSO Epimed International, Inc.	Versa-Kath	2008-04-16
PMN K023140 | BSO EPIMED INTERNATIONAL, INC.	Versa-Kath	2008-04-16
PMN K022029 | BSP Epimed International, Inc.	Quincke Spinal Needle	2008-04-16
PMN K022029 | BSP Epimed International, Inc.	Chiba Needle	2008-04-16
PMN K022029 | BSP EPIMED INTERNATIONAL, INC.	Quincke Spinal Needle	2008-04-16
PMN K022029 | BSP EPIMED INTERNATIONAL, INC.	Chiba Needle	2008-04-16
PMN K020926 | FPA Epimed International, Inc.	Extension Set	2008-04-16
PMN K020926 | FPA EPIMED INTERNATIONAL, INC.	Extension Set	2008-04-16
PMN K053318 EPIMED INTERNATIONAL, INC.	RX EPIDURAL NEEDLE	2006-02-17
PMN K051171 EPIMED INTERNATIONAL, INC.	STINGRAY EPIDURAL CATHETER CONNECTOR	2005-08-26
PMN K051860 EPIMED INTERNATIONAL, INC.	FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837	2005-08-22
PMN K043467 EPIMED INTERNATIONAL, INC.	FLEXIBLE SPINAL NEEDLE	2005-03-31
PMN K041021 EPIMED INTERNATIONAL, INC.	RF INTRODUCTION CANNULA	2004-09-16
PMN K041843 EPIMED INTERNATIONAL, INC.	PENCIL POINT NEEDLE	2004-08-24
PMN K023140 EPIMED INTERNATIONAL, INC.	VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124	2003-08-15
PMN K030562 EPIMED INTERNATIONAL, INC.	TUOHY EPIDURAL NEEDLE	2003-04-03
PMN K022029 EPIMED INTERNATIONAL, INC.	QUINCKE SPINAL NEEDLE	2002-07-30
PMN K020926 EPIMED INTERNATIONAL, INC.	EXTENSION SET, MODELS 1911-512	2002-07-12
PMN K981329 EPIMED INTERNATIONAL, INC.	FETH-R-KATH	1998-08-26
GCE Epimed International, Inc.	Catheter Connector	1992-07-27
GCE EPIMED INTERNATIONAL, INC.	Catheter Connector	1992-07-27

Related Finance Registrations

NCAGE Code	35MK9	EPIMED INTERNATIONAL, INC
CAGE Code	35MK9	EPIMED INTERNATIONAL, INC
S.A.M. Registration	35MK9 [799751953]	EPIMED INTERNATIONAL, INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081832096	Taipei,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE	13 CTN
2020080676518	Taipei,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE	13 CTN
2020030242014	Kaohsiung,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE	13 CTN
2020022631340	Kaohsiung,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE	13 CTN
2019112149633	Kaohsiung,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PADG1 TYPE LIST ING NEUMBER D186929 PREMARKET SUBMISSION NUM BERY 510K K121268 REGISTRATION NUMBER 00374 9270	13 CTN
2019091347026	Kaohsiung,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE LIST ING NUMBER D186929 PREMARKET SUBMISSION NUMB ER 510K K121268 REGISTRATION NUMBER 3003749 270PI B1 19 WA 056 LOT NO FOR THIS SHIPMEN T BAW190742	13 CTN
2019071153017	Kaohsiung,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE LIST ING NUMBER D186929 PREMARKET SUBMISSION NUMB ER 510 K K 121268 PEGISTRAION MUBER 3003749 270 PI B1 18 WA 079 LOT NO POR THIS SHIPMEN T BAW190501	13 CTN
2019040312335	Kaohsiung,China (Taiwan) -> Los Angeles, California	WANDY DISPOSABLE GROUNDING PAD G1 TYPE 510K 121268 D186929 PI B1 18 WA 079 LOT NO FOR THIS SHIPMENT BAW181201	13 CTN