Dreve Otoplastik G M B H

FDA Filings

This page includes the latest FDA filings for Dreve Otoplastik G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003610251
• FEI Number: 3003610251
• Name: Mike Kollar
• Owner & Operator: DREVE OTOPLASTIK GMBH
• Contact Address: Max-Planck-Strasse 31 --; UNNA DE-NW Nordrhein-Westfalen 59423 DE
• US Agent:
  • Mike Kollar
  • DREVE AMERICA CORP.
  • 612 3238803
  • michael.kollar@dreve-america.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6477 City West Pkwy ; Eden Prairie, MN 55344 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID E23928322M1 Dreve Otoplastik GmbH	Biopor® AB 28322M	2024-05-08
GUDID E23928362M1 Dreve Otoplastik GmbH	Biopor® AB 28362M	2024-05-07
GUDID E239283621 Dreve Otoplastik GmbH	Biopor® AB 28362	2024-05-07
GUDID E23928332M1 Dreve Otoplastik GmbH	Biopor® AB 28332M	2024-05-07
GUDID E239283321 Dreve Otoplastik GmbH	Biopor® AB 28332	2024-05-07
GUDID E239283221 Dreve Otoplastik GmbH	Biopor® AB 28322	2024-05-07
GUDID E23928312M1 Dreve Otoplastik GmbH	Biopor® AB 28312M	2024-05-07
GUDID E239283121 Dreve Otoplastik GmbH	Biopor® AB 28312	2024-05-07
GUDID E23928303M1 Dreve Otoplastik GmbH	Biopor® AB 28303M	2024-05-07
GUDID E239283031 Dreve Otoplastik GmbH	Biopor® AB 28303	2024-05-07
GUDID E23928215M1 Dreve Otoplastik GmbH	Biopor® AB 28215M	2024-05-07
GUDID E239282151 Dreve Otoplastik GmbH	Biopor® AB 28215	2024-05-07
GUDID E23928207M1 Dreve Otoplastik GmbH	Biopor® AB 28207M	2024-05-07
GUDID E239282071 Dreve Otoplastik GmbH	Biopor® AB 28207	2024-05-07
GUDID E23928117M1 Dreve Otoplastik GmbH	Biopor® AB 28117M	2024-05-07
GUDID E239281171 Dreve Otoplastik GmbH	Biopor® AB 28117	2024-05-07
GUDID E23928114M1 Dreve Otoplastik GmbH	Biopor® AB 28114M	2024-05-07
GUDID E239281141 Dreve Otoplastik GmbH	Biopor® AB 28114	2024-05-07
GUDID E2398802ST1 Dreve Otoplastik GmbH	Otoform® A softX 8802ST	2024-03-21
GUDID E2398802AU1 Dreve Otoplastik GmbH	Otoform® A softX 8802AU	2024-03-21
GUDID E239204211 Dreve Otoplastik GmbH	Small nylon tubing 20421	2024-03-13
GUDID E2392042101 Dreve Otoplastik GmbH	Small nylon tubing 204210	2024-03-13
GUDID E2392041101 Dreve Otoplastik GmbH	Arc tubing connection 204110	2024-03-13
GUDID E23920411001 Dreve Otoplastik GmbH	Arc tubing connection 2041100	2024-03-13
GUDID E2398802M1 Dreve Otoplastik GmbH	Otoform® A softX 8802M	2023-12-26
GUDID E23988021 Dreve Otoplastik GmbH	Otoform® A softX 8802	2023-11-08
GUDID E23942511 Dreve Otoplastik GmbH	Biopor® UV-S 4251	2023-10-19
GUDID E239249551 Dreve Otoplastik GmbH	FotoTec® DLP.A 24955	2023-07-03
GUDID E239043101 Dreve Otoplastik GmbH	Pre-bent tubing 04310	2023-03-17
GUDID E2390431001 Dreve Otoplastik GmbH	Pre-bent tubing 043100	2023-03-17
GUDID E239448411 Dreve Otoplastik GmbH	Fotoplast® Gel 44841	2023-01-12
GUDID E239448311 Dreve Otoplastik GmbH	Fotoplast® Gel 44831	2023-01-12
GUDID E239288632M1 Dreve Otoplastik GmbH	Biopor® AB Xtreme 288632M	2023-01-12
GUDID E239244001 Dreve Otoplastik GmbH	FotoTec® DLP.A 24400	2023-01-12
GUDID E2392311001 Dreve Otoplastik GmbH	Arc tubing connection 231100	2023-01-12
GUDID E2397431 Dreve Otoplastik GmbH	Precise II 743	2022-12-13
GUDID E23928321M1 Dreve Otoplastik GmbH	Biopor® AB 28321M	2022-08-29
GUDID E239283211 Dreve Otoplastik GmbH	Biopor® AB 28321	2022-08-29
GUDID E23928311M1 Dreve Otoplastik GmbH	Biopor® AB 28311M	2022-08-29
GUDID E239283111 Dreve Otoplastik GmbH	Biopor® AB 28311	2022-08-29
GUDID E23928301M1 Dreve Otoplastik GmbH	Biopor® AB 28301M	2022-08-29
GUDID E239283011 Dreve Otoplastik GmbH	Biopor® AB 28301	2022-08-29
GUDID E23928293M1 Dreve Otoplastik GmbH	Biopor® AB 28293M	2022-08-29
GUDID E239282931 Dreve Otoplastik GmbH	Biopor® AB 28293	2022-08-29
GUDID E23928292M1 Dreve Otoplastik GmbH	Biopor® AB 28292M	2022-08-29
GUDID E239282921 Dreve Otoplastik GmbH	Biopor® AB 28292	2022-08-29
GUDID E23928291M1 Dreve Otoplastik GmbH	Biopor® AB 28291M	2022-08-29
GUDID E239282911 Dreve Otoplastik GmbH	Biopor® AB 28291	2022-08-29
GUDID E23928290M1 Dreve Otoplastik GmbH	Biopor® AB 28290M	2022-08-29
GUDID E239282901 Dreve Otoplastik GmbH	Biopor® AB 28290	2022-08-29
GUDID E23928272M1 Dreve Otoplastik GmbH	Biopor® AB 28272M	2022-08-29
GUDID E239282721 Dreve Otoplastik GmbH	Biopor® AB 28272	2022-08-29
GUDID E23928262M1 Dreve Otoplastik GmbH	Biopor® AB 28262M	2022-08-29
GUDID E239282621 Dreve Otoplastik GmbH	Biopor® AB 28262	2022-08-29
GUDID E23928252M1 Dreve Otoplastik GmbH	Biopor® AB 28252M	2022-08-29
GUDID E239282521 Dreve Otoplastik GmbH	Biopor® AB 28252	2022-08-29
GUDID E23928242M1 Dreve Otoplastik GmbH	Biopor® AB 28242M	2022-08-29
GUDID E239282421 Dreve Otoplastik GmbH	Biopor® AB 28242	2022-08-29
GUDID E23928232M1 Dreve Otoplastik GmbH	Biopor® AB 28232M	2022-08-29
GUDID E239282321 Dreve Otoplastik GmbH	Biopor® AB 28232	2022-08-29
GUDID E23928222M1 Dreve Otoplastik GmbH	Biopor® AB 28222M	2022-08-29
GUDID E239282221 Dreve Otoplastik GmbH	Biopor® AB 28222	2022-08-29
GUDID E23928212M1 Dreve Otoplastik GmbH	Biopor® AB 28212M	2022-08-29
GUDID E239282121 Dreve Otoplastik GmbH	Biopor® AB 28212	2022-08-29
GUDID E23928211M1 Dreve Otoplastik GmbH	Biopor® AB 28211M	2022-08-29
GUDID E239282111 Dreve Otoplastik GmbH	Biopor® AB 28211	2022-08-29
GUDID E23928204M1 Dreve Otoplastik GmbH	Biopor® AB 28204M	2022-08-29
GUDID E239282041 Dreve Otoplastik GmbH	Biopor® AB 28204	2022-08-29
GUDID E23928203M1 Dreve Otoplastik GmbH	Biopor® AB 28203M	2022-08-29
GUDID E239282031 Dreve Otoplastik GmbH	Biopor® AB 28203	2022-08-29
GUDID E23928202M1 Dreve Otoplastik GmbH	Biopor® AB 28202M	2022-08-29
GUDID E239282021 Dreve Otoplastik GmbH	Biopor® AB 28202	2022-08-29
GUDID E23928201M1 Dreve Otoplastik GmbH	Biopor® AB 28201M	2022-08-29
GUDID E239282011 Dreve Otoplastik GmbH	Biopor® AB 28201	2022-08-29
GUDID E23928200M1 Dreve Otoplastik GmbH	Biopor® AB 28200M	2022-08-29
GUDID E23928124M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28124M	2022-08-29
GUDID E239281241 Dreve Otoplastik GmbH	Biopor® AB monitoring 28124	2022-08-29
GUDID E23928123M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28123M	2022-08-29
GUDID E23928122M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28122M	2022-08-29
GUDID E239281221 Dreve Otoplastik GmbH	Biopor® AB monitoring 28122	2022-08-29
GUDID E23928121M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28121M	2022-08-29
GUDID E239281211 Dreve Otoplastik GmbH	Biopor® AB monitoring 28121	2022-08-29
GUDID E23928120M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28120M	2022-08-29
GUDID E239281201 Dreve Otoplastik GmbH	Biopor® AB monitoring 28120	2022-08-29
GUDID E23928113M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28113M	2022-08-29
GUDID E239281131 Dreve Otoplastik GmbH	Biopor® AB monitoring 28113	2022-08-29
GUDID E23928111M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28111M	2022-08-29
GUDID E239281111 Dreve Otoplastik GmbH	Biopor® AB monitoring 28111	2022-08-29
GUDID E23928109M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28109M	2022-08-29
GUDID E239281091 Dreve Otoplastik GmbH	Biopor® AB monitoring 28109	2022-08-29
GUDID E23928108M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28108M	2022-08-29
GUDID E239281081 Dreve Otoplastik GmbH	Biopor® AB monitoring 28108	2022-08-29
GUDID E23928107M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28107M	2022-08-29
GUDID E239281071 Dreve Otoplastik GmbH	Biopor® AB monitoring 28107	2022-08-29
GUDID E23928106M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28106M	2022-08-29
GUDID E239281061 Dreve Otoplastik GmbH	Biopor® AB monitoring 28106	2022-08-29
GUDID E23928105M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28105M	2022-08-29
GUDID E239281051 Dreve Otoplastik GmbH	Biopor® AB monitoring 28105	2022-08-29
GUDID E23928101M1 Dreve Otoplastik GmbH	Biopor® AB monitoring 28101M	2022-08-29
GUDID E239281011 Dreve Otoplastik GmbH	Biopor® AB monitoring 28101	2022-08-29
LDG Mike Kollar [DREVE OTOPLASTIK GMBH]	mixing cannulas	2018-02-26
LDG Mike Kollar [DREVE OTOPLASTIK GMBH]	manual injector	2018-02-26
LDG Mike Kollar [DREVE OTOPLASTIK GMBH]	impression syringe	2018-02-26
LDG Mike Kollar [DREVE OTOPLASTIK GMBH]	impression pads	2018-02-26
LDG Mike Kollar [DREVE OTOPLASTIK GMBH]	ear impression material	2018-02-26
ERA Mike Kollar [DREVE OTOPLASTIK GMBH]	Multiple	2012-11-02
MNE Mike Kollar [DREVE OTOPLASTIK GMBH]	Multiple	2009-08-21
LRJ Mike Kollar [DREVE OTOPLASTIK GMBH]	Multiple	2001-04-10
ESD Mike Kollar [DREVE OTOPLASTIK GMBH]	Multiple	2000-05-01
EID Mike Kollar [DREVE OTOPLASTIK GMBH]	Multiple	1997-11-06

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092375293	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	FLAMMABLE LIQUID, N.O.S. (HEXAMETHYLDISILOXAN E)	28 BOX
2020092375293	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	TOLUENE, SOLUTION LIMITED QUANTITY	28 BOX
2020092375293	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	HYDROCARBONS, LIQUID, N.O.S.	28 BOX
2020092375293	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	METHYL METHACRYLATE MONOMER, STABILIZED, SOLU TION	28 BOX
2020092375293	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OTOPLASTIC PRODUCTS HS 391000	28 BOX
2020052053923	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OTOPLASTIC PRODUCTS HS-CODE: 391000	20 CTN
2020042349378	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OTOPLASTIC PRODUCTSHS CODE 39100000 39069090 39069090	11 BOX
2020032611536	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SILICONEHS CODE 39100000 39069090 90183110 .	8 BOX
2020032150625	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OTOPLASTIC PRODUCTS	21 CTN
2020032150625	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	METHYL METHACRYLATE MONOMER,STABILIZED,SOLUTI ONHS-CODE: 3906	21 CTN
2020032123038	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SILICONEHS CODE 39100000 39069090 90183110 .	8 BOX
2020031641261	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SILICONEHS CODE 39100000 39069090 90183110 .	8 BOX
2020030938029	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PALGROSSHS CODE 39100000 .	2 CTN