GYNEMED GMBH & CO. KG

FDA Device Registration & Listing · Sierksdorf Schleswig-Holstein, DE · Registration 3030390242

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030390242
FEI Number
3030390242
Entity Name
GYNEMED GMBH & CO. KG
City/State/Country
Sierksdorf Schleswig-Holstein, DE
Establishment Address
Wagrienring 24b, Sierksdorf Schleswig-Holstein 23730, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GYNEMED GmbH & Co. KG (Owner Number: 10091740)
Owner / Operator Contact Address
Wagrienring 24b, Sierksdorf, DE-SH 23730, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191552
PMA Number
N/A

All Registered Proprietary Names

GM501 SpermAir GM501 SpermActive GM501 Wash with Phenolred and Gentamicin GM501 MineralOil

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2024-12-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2024-12-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2024-12-11

Official Correspondent

Dr. Julia Heinzmann

US Agent Details

Nicole Thibodeau Business: Hamilton Thorne, Inc. Email: nthibodeau@hamiltonthorne.com Phone: (978) 9212050

Related Public Records

Same Entity

GYNEMED GmbH & Co. KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030390242. Last updated year: 2026. Please use registration number 3030390242 when referencing this establishment in official correspondence.
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