Standard Instruments GmbH
Germany DE-MF-000013833 Last updated 21 Oct 2026
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- Devices
- 8
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
What Standard Instruments GmbH makes
Standard Instruments GmbH manufactures medical imaging and diagnostic devices, including the Imphora system for gastrointestinal imaging and the ViMeDat platform for reflux and motility analysis. The ZALT device is also part of their portfolio, designed for specific gastrointestinal assessments. These products are primarily used in clinical settings for diagnostic evaluations of the digestive system.
The company’s devices are classified under EU Class IIa and are registered in the EU’s eudamed database. Their portfolio adheres to European medical device regulations, ensuring compliance with relevant safety and performance standards. The manufacturer is based in Germany.
Frequently asked questions
What medical devices does Standard Instruments GmbH manufacture?
Standard Instruments GmbH produces medical imaging and diagnostic devices, including the Imphora system for gastrointestinal imaging, the ViMeDat platform for reflux and motility analysis, and the ZALT device for specific gastrointestinal assessments.
Where is Standard Instruments GmbH based?
The company is based in Germany, as indicated by the country code DE in their device registration information.
Which regulatory registries list Standard Instruments GmbH's devices?
The company's devices are listed in the EU's eudamed database, which is the European medical device database for registration and vigilance purposes.
How are Standard Instruments GmbH's devices classified?
The company's medical devices are classified under EU Class IIa, which means they are medium-risk devices requiring specific conformity assessment procedures before being placed on the market.
Information
- Country
- Germany
- Address
- 12, Werftstrasse, Karlsruhe, Germany
- Website
- www.stdi.de
- [email protected]
- PRRC contact
- Sven Krämer
- EUDAMED SRN
- DE-MF-000013833