Osypka AG
Germany DE-MF-000005610 Last updated 22 Oct 2026
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- Devices
- 56
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
VACS III 18.0 x 40 Ref YA31840
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iCONNECT - AMPERE 82066 Ref 82066
MAGiC Magnetic Interventional Ablation Catheter 8C-21-031Z-B Ref 8C-21-031Z-B
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VACS III 12.0 x 40 Ref YA31240
VACS III 15.0 x 40 Ref YA31540
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VACS II 26.0 x 40 Ref YA0059
VACS II 20.0 x 60 Ref YA0050
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What Osypka AG makes
Osypka AG manufactures the TME Temporary Myocardial Electrode, a device designed for temporary cardiac monitoring and stimulation during surgical procedures.
The TME Temporary Myocardial Electrode is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Osypka AG manufacture?
Osypka AG specializes in the TME Temporary Myocardial Electrode, a device used for temporary cardiac monitoring and stimulation during surgical interventions. This product is tailored for short-term clinical needs where precise heart function assessment or stimulation is required.
Where is Osypka AG based, and how does that affect its regulatory approach?
Osypka AG is based in the United States, which means its devices are subject to FDA regulations. The TME Temporary Myocardial Electrode is classified as a Class II device, indicating it poses moderate risk and requires compliance with specific FDA requirements, including the 510(k) clearance pathway for market authorization.
Which regulatory registries or databases list Osypka AG’s devices?
Osypka AG’s TME Temporary Myocardial Electrode is listed under the FDA’s 510(k) pathway, meaning it has undergone the required pre-market notification process to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures its compliance with U.S. regulatory standards.
How are Osypka AG’s devices classified under medical device regulations?
The TME Temporary Myocardial Electrode is classified as a Class II medical device by the FDA. This classification is based on its intended use—temporary cardiac monitoring and stimulation—which carries moderate risk. Class II devices require special controls beyond general controls to ensure safety and effectiveness, including performance standards and post-market surveillance.
Information
- Country
- Germany
- Address
- 1, Earl-H.-Wood-Str., Rheinfelden, Germany
- Website
- www.osypka.de
- [email protected]
- Phone
- +49 7623 7405 0
- PRRC contact
- Achim Kitschmann
- EUDAMED SRN
- DE-MF-000005610