Mermaid Medical A S

FDA Filings

This page includes the latest FDA filings for Mermaid Medical A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007146453
• FEI Number: 3007146453
• Name: MERMAID MEDICAL A/S
• Owner & Operator: Mermaid Medical A/S
• Contact Address: Frydensbergvej 25 ; Stenloese DK-84 Region Hovedstaden DK-3660 DK
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Importing Logistics Registration:
  • Importer: Mermaid Medical Inc
  • Address: Dry Ceel Business Park 7340 South Alton ; Centennial, CO 80112 UNITED STATES
  • Email Address: lv@mermaidmedical.com
  • Phone: 1 724 7130151
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Frydensbergvej 25 ; Stenloese Region Hovedstaden, DK-3660 DK
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 25711055120450 Mermaid Medical A/S	M-Drain D12014045	2024-02-08
GUDID 25711055120047 Mermaid Medical A/S	M-Drain D12012040	2024-02-08
GUDID 25711055001759 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20420020	2023-10-11
GUDID 25711055001698 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20416016	2023-10-11
GUDID 25711055001643 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20320020	2023-10-11
GUDID 25711055001520 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20220010	2023-10-11
GUDID 25711055001834 Mermaid Medical A/S	M-Drain DS2010400	2023-10-04
GUDID 25711055001827 Mermaid Medical A/S	M-Drain DS2010300	2023-10-04
GUDID 25711055001810 Mermaid Medical A/S	M-Drain DS2010200	2023-10-04
GUDID 25711055001780 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20420013	2023-10-04
GUDID 25711055001773 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20418013	2023-10-04
GUDID 25711055001766 Mermaid Medical A/S	M-Drain DS2010100	2023-10-04
GUDID 25711055001742 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20420016	2023-10-04
GUDID 25711055001735 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20420010	2023-10-04
GUDID 25711055001728 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20418020	2023-10-04
GUDID 25711055001711 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20418016	2023-10-04
GUDID 25711055001704 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20418010	2023-10-04
GUDID 25711055001681 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20416010	2023-10-04
GUDID 25711055001674 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20414016	2023-10-04
GUDID 25711055001667 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20414010	2023-10-04
GUDID 25711055001636 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20320016	2023-10-04
GUDID 25711055001629 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20320010	2023-10-04
GUDID 25711055001612 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20318020	2023-10-04
GUDID 25711055001605 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20318016	2023-10-04
GUDID 25711055001599 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20318010	2023-10-04
GUDID 25711055001582 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20316016	2023-10-04
GUDID 25711055001575 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20316010	2023-10-04
GUDID 25711055001568 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20314016	2023-10-04
GUDID 25711055001551 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20314010	2023-10-04
GUDID 25711055001544 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20220020	2023-10-04
GUDID 25711055001537 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20220016	2023-10-04
GUDID 25711055001513 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20218030	2023-10-04
GUDID 25711055001506 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20218025	2023-10-04
GUDID 25711055001490 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20218020	2023-10-04
GUDID 25711055001483 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20218016	2023-10-04
GUDID 25711055001476 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20218010	2023-10-04
GUDID 25711055001469 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20216020	2023-10-04
GUDID 25711055001452 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20216016	2023-10-04
GUDID 25711055001445 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20216010	2023-10-04
GUDID 25711055001438 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20214020	2023-10-04
GUDID 25711055001421 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20214016	2023-10-04
GUDID 25711055001414 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20214012	2023-10-04
GUDID 25711055001407 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20120016	2023-10-04
GUDID 25711055001391 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20120013	2023-10-04
GUDID 25711055001384 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20120010	2023-10-04
GUDID 25711055001377 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20118030	2023-10-04
GUDID 25711055001360 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20118025	2023-10-04
GUDID 25711055001353 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20118020	2023-10-04
GUDID 25711055001346 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20118016	2023-10-04
GUDID 25711055001339 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20118013	2023-10-04
GUDID 25711055001322 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20116020	2023-10-04
GUDID 25711055001315 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20116016	2023-10-04
GUDID 25711055001308 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20116013	2023-10-04
GUDID 25711055001292 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20116010	2023-10-04
GUDID 25711055001285 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20114020	2023-10-04
GUDID 25711055001278 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20114016	2023-10-04
GUDID 25711055001261 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20114013	2023-10-04
GUDID 25711055001254 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20214010	2023-10-04
GUDID 25711055001247 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20114010	2023-10-04
GUDID 25711055001230 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20118010	2023-10-04
GUDID 25711055001223 Mermaid Medical A/S	M-Biopsy Needle For Reusable Biopsy Instruments N20120020	2023-10-04
GUDID 05711055001922 Mermaid Medical A/S	Access Needle N12021200	2022-10-10
GUDID 05711055001915 Mermaid Medical A/S	Access Needle N12121150	2022-10-10
GUDID 05711055001908 Mermaid Medical A/S	Access Needle N12021150	2022-10-10
GUDID 05711055000307 Mermaid Medical A/S	Access Needle N12118200	2022-10-10
GUDID 05711055000291 Mermaid Medical A/S	Access Needle N12118150	2022-10-10
GUDID 05711055000284 Mermaid Medical A/S	Access Needle N10222300	2022-10-10
GUDID 05711055000277 Mermaid Medical A/S	Access Needle N10222250	2022-10-10
GUDID 05711055000260 Mermaid Medical A/S	Access Needle N10222200	2022-10-10
GUDID 05711055000086 Mermaid Medical A/S	Access Needle N12218150	2022-10-10
GUDID 05711055000062 Mermaid Medical A/S	Access Needle N12018200	2022-10-10
GUDID 05711055000055 Mermaid Medical A/S	Access Needle N12018150	2022-10-10
GUDID 15711055005002 Mermaid Medical A/S	Angel Catheter	2022-10-06
GUDID 05711055002011 Mermaid Medical A/S	M-Drain Centesis Catheter D40105020	2020-09-09
GUDID 05711055002004 Mermaid Medical A/S	M-Drain Centesis Catheter D40105015	2020-09-09
GUDID 05711055001991 Mermaid Medical A/S	M-Drain Centesis Catheter D40105010	2020-09-09
GUDID 05711055001984 Mermaid Medical A/S	M-Drain Centesis Catheter D40105007	2020-09-09
GUDID 05711055001977 Mermaid Medical A/S	M-Drain Centesis Catheter D40104015	2020-09-09
GUDID 05711055001960 Mermaid Medical A/S	M-Drain Centesis Catheter D40104010	2020-09-09
GUDID 15711055004333 Mermaid Medical A/S	D*Clot® HD Rotational Thrombectomy System T10106065	2020-03-24
GUDID 15711055004326 Mermaid Medical A/S	D*Clot® HD Rotational Thrombectomy System T10106040	2020-03-24
PMN K021641 | DXE MERMAID MEDICAL A/S	DCLOT MD Rotational Thrombectomy Catheter	2020-03-12
PMN K013473 | MCW MERMAID MEDICAL A/S	CDLOT MD Rotational Thrombectomy Catheter	2020-03-12
PMN K935170 | DQX MERMAID MEDICAL A/S	Angel? Catheter Accesory Kit	2019-11-27
PMN K160747 | PNS MERMAID MEDICAL A/S	Angel? Catheter	2019-11-27
PMN K160747 | PNS MERMAID MEDICAL A/S	Angel? Catheter Accessory Kit	2019-11-27
GUDID 05711055000673 Mermaid Medical A/S	M-Drain D10510025	2018-07-06
GUDID 05711055000666 Mermaid Medical A/S	M-Drain D10510020	2018-07-06
GUDID 05711055000635 Mermaid Medical A/S	M-Drain D10508025	2018-07-06
GUDID 05711055000628 Mermaid Medical A/S	M-Drain D10508020	2018-07-06
GUDID 05711055000598 Mermaid Medical A/S	M-Drain D10507025	2018-07-06
GUDID 05711055000581 Mermaid Medical A/S	M-Drain D10507020	2018-07-06
GUDID 05711055000550 Mermaid Medical A/S	M-Drain D10506025	2018-07-06
GUDID 05711055000536 Mermaid Medical A/S	M-Drain D14514040	2018-07-06
GUDID 05711055000512 Mermaid Medical A/S	M-Drain D14512040	2018-07-06
GUDID 05711055000499 Mermaid Medical A/S	M-Drain D14510040	2018-07-06
GUDID 05711055000475 Mermaid Medical A/S	M-Drain D14508040	2018-07-06
GUDID 05711055000451 Mermaid Medical A/S	M-Drain D14014040	2018-07-06
GUDID 05711055000437 Mermaid Medical A/S	M-Drain D14012040	2018-07-06
GUDID 05711055000413 Mermaid Medical A/S	M-Drain D14010040	2018-07-06
GUDID 05711055000390 Mermaid Medical A/S	M-Drain D14008040	2018-07-06
GUDID 05711055000376 Mermaid Medical A/S	M-Drain D13010025	2018-07-06
GUDID 05711055000352 Mermaid Medical A/S	M-Drain D13008025	2018-07-06
GUDID 05711055000321 Mermaid Medical A/S	M-Drain D13006020	2018-07-06
GUDID 05711055000314 Mermaid Medical A/S	M-Drain D13006015	2018-07-06
PMN K161409 | KNW MERMAID MEDICAL A/S	M-Biopsy, Semi-Automatic Biopsy Instrument and Coaxial Needle	2016-09-16
PMN K161409 Mermaid Medical A/S	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle For Sem	2016-08-02
PMN K071330 | DRE MERMAID MEDICAL A/S	M-Drain Percutaneous Introducer System	2013-11-29
PMN K033862 | LJE MERMAID MEDICAL A/S	M-Drain	2013-11-21
PMN K033862 | FGE MERMAID MEDICAL A/S	M-Drain	2013-11-21
DWO MERMAID MEDICAL A/S	M-Biopsy	2013-11-21
GCB MERMAID MEDICAL A/S	M-Drain Centesis Catheter	2013-10-31
GCB MERMAID MEDICAL A/S	Access Needle	2013-10-31
GAA MERMAID MEDICAL A/S	Fine Needle Aspiration	2013-10-31

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018060521834	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	MEDICAL EQUIPMENT	48 PKG
2018052549799	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	MEDICAL EQUIPMENT	2 PKG
2018050247448	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	SURGICAL INSTRUMENTS HS 9018.32	4 PAL