Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681449

FEI Number

3007486998

Entity Name

OSYPKA MEDICAL GMBH

City/State/Country

BERLIN, DE

Establishment Address

Albert-Einstein-Strasse 3, BERLIN 12489, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osypka Medical GmbH (Owner Number: 9029408)

Owner / Operator Contact Address

Albert-Einstein-Strasse 3, --, Berlin, DE-NOTA D-12489, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020896

PMA Number

N/A

All Registered Proprietary Names

PSA 100 PSA 200 ICON AESCULON PACE 203H PACE 203 Model 3085

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2013-05-20
DTA	Tester, Pacemaker Electrode Function	Cardiovascular	Class 2	870.3720	2013-05-20
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2008-12-10
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2008-12-10
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2007-10-31

Official Correspondent

Thilo Thuemecke

US Agent Details

Markus Osypka Business: OSYPKA MEDICAL, INC. Email: M.OSYPKA@OSYPKAMED.COM Phone: (858) 4540600

Related Public Records

Same Entity

Osypka Medical 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 9681449. Last updated year: 2026. Please use registration number 9681449 when referencing this establishment in official correspondence.