Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003923762

FEI Number

3003923762

Entity Name

OSYPKA GmbH

City/State/Country

Rheinfelden Baden-Wurttemberg, DE

Establishment Address

Earl-H.-Wood-Str. 1, Rheinfelden Baden-Wurttemberg 79618, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Osypka GmbH (Owner Number: 10048738)

Owner / Operator Contact Address

Earl-H.-Wood-Str. 1, Rheinfelden, DE-BW 79618, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OSYPKA TME pacing wires Revi Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2026-02-20
QXM	Implanted Tibial Electrical Urinary Continence Device	Gastroenterology, Urology	Class 2	876.5305	2023-11-27

Official Correspondent

Nicola Osypka

US Agent Details

Alan Van Houten Business: Biomedical Consulting Email: alanvanhouten@hotmail.com Phone: (952) 9392987

Related Public Records

Same Entity

Osypka GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003923762. Last updated year: 2026. Please use registration number 3003923762 when referencing this establishment in official correspondence.