STRATEC MEDIZINTECHNIK GMBH
Germany DE-MF-000015366 Last updated 23 Oct 2026
- Devices
- 1
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Leonardo GRFP STD MED Ref 8N600455
FDA establishments
- Stratec Medizintechnik GmbH US
What STRATEC MEDIZINTECHNIK GMBH makes
STRATEC Medizintechnik GmbH manufactures the Leonardo GRFP STD MED, a medical device classified as Class I.
The device is regulated under the European Union's medical device framework and is listed in the EUDAMED database. The company is based in Germany.
Frequently asked questions
What medical device does STRATEC Medizintechnik GmbH manufacture?
The only device mentioned for STRATEC Medizintechnik GmbH is the Leonardo GRFP STD MED. This conclusion comes directly from the provided data, which lists that model as the example device produced by the company.
Where is STRATEC Medizintechnik GmbH located?
The company is based in Germany, as indicated by the COUNTRY field set to DE in the supplied information. This geographic detail is explicitly stated and requires no inference beyond reading the data.
In which regulatory registry are STRATEC Medizintechnik GmbH's devices listed?
The Leonardo GRFP STD MED is listed in the European Union's EUDAMED database. The LISTED IN field specifies "eudamed," and the summary confirms that the device is registered there under EU medical device regulations.
How is the Leonardo GRFP STD MED classified under EU regulations?
The device is classified as Class I. This classification is directly provided in the DEVICE CLASSES entry and reiterated in the summary, indicating it falls under the lowest risk category for medical devices in the EU framework.
Information
- Country
- Germany
- Address
- 35, Durlacher Strasse, Pforzheim, Germany
- Website
- stratec-med.com
- [email protected]
- PRRC contact
- Harald Schubert
- EUDAMED SRN
- DE-MF-000015366
- FDA FEI number
- 1000646577