Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016126174

FEI Number

3016126174

Entity Name

VITROMED GmbH

City/State/Country

Langenfeld (Rheinland) North Rhine-Westphalia, DE

Establishment Address

Raiffeisen Str 15a, Langenfeld (Rheinland) North Rhine-Westphalia 40764, DE

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198

Owner / Operator

VITROMED GmbH (Owner Number: 10062050)

Owner / Operator Contact Address

Goschwitzer Str. 22, Jena, DE-NOTA 07745, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

V-GRAD V-ONESTEP V-PVP V-DENUPET V-VITWARM (V-TS-KIT: V-THAWING SOLUTION; V-TS-4) V-VITFREEZE (V-FS-KIT: V-EQUILIBRATION SOLUTION; V-ES-2) V-VITWARM (V-TS-KIT: V-WASHING SOLUTION; V-WS-4) V-VITFREEZE (V-FS-KIT: V-VITRIFICATION SOLUTION; V-VS-2) V-VITWARM (V-TS-KIT: V-DILUENT SOLUTION; V-DS-4) V-HEPES PLUS V-HYADASE V-ICSIPET V-SPERM WASH V-OIL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2025-04-03
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-01-07
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-03-22
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2021-01-07
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-09-18
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2022-11-21
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2023-06-22
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2019-12-13
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2023-02-03
QKI	Media, Reproductive, Exempt	Obstetrics/Gynecology	Class 2	884.6180	2022-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

VITROMED GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016214552	VITROMED GMBH	Jena Thuringia, DE
3042228693	VITROMED SMPC	Ilion Attiki, GR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

Similar Registrations

Registration Number	Establishment Name	Location
2031824	Vitrolife Inc.	San Diego, CA, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016126174. Last updated year: 2026. Please use registration number 3016126174 when referencing this establishment in official correspondence.