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Sign in to claim this brandMolzym GmbH & Co.KG
Germany·DE-MF-000037419
Last updated September 17, 2026
What Molzym GmbH & Co.KG makes
Molzym GmbH & Co.KG produces in vitro diagnostic (IVD) kits for nucleic acid extraction and isolation, including systems for detecting microbial pathogens and genetic material. Their portfolio includes specialized reagents and add-ons for sepsis testing, such as the SepsiTest™-UMD and Micro-Dx™ kits, as well as the MolYsis-SNplus™ for sample preparation. The UMD-SelectNA™ is designed for targeted nucleic acid isolation from clinical specimens.
These devices are classified under Class A and IVD General categories, with regulatory authorisation via the CE marking process. They are registered in the EU’s eudamed database, reflecting compliance with European Union In Vitro Diagnostic Regulation (IVDR). The company is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 10, Mary-Astell-Str., Bremen, Germany
- Website
- molzym.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Michael Lustig
- EUDAMED SRN
- DE-MF-000037419
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SepsiTest™-UMD CE IVD | U-010-024 | EUDAMED | IVD General | Active |
| Micro-Dx™ CE IVD | U-200-024 | EUDAMED | IVD General | Active |
| Micro-Dx™ CE IVD | U-200-048 | EUDAMED | IVD General | Active |
| Add-On 10 CE IVD | U-120-048 | EUDAMED | IVD General | Active |
| SepsiTest™-UMD CE IVD | U-010-048 | EUDAMED | IVD General | Active |
| MolYsis-SNplus™ IVD | U-300-048 | EUDAMED | Class A | Active |
| UMD-SelectNA™ CE IVD | U-050-024 | EUDAMED | IVD General | Active |
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