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UMD-SelectNA™ CE IVD
EUDAMEDClass IVD General (EU MDR)
Ref U-050-024Ref U-050-048
Identity
- Trade Name
- UMD-SelectNA™ CE IVD EUDAMED
- Device Name
- UMD-SelectNA™ CE IVD EUDAMED
- Model / Reference
- U-050-024 EUDAMEDU-050-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-U-050-0244R EUDAMEDD-U-050-04857 EUDAMED
- Basic UDI-DI
- B-U-050-0244R EUDAMEDB-U-050-04857 EUDAMED
- EMDN Code
- W0105900101,W0105900102 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
UMD-SelectNA™ CE IVD by Molzym GmbH & Co.KG — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-U-050-0244R | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Molzym GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000037419
Sources (4)
- EUDAMED 39b2cd3a-5248-4bbe-8b5b-96871315a7ac 61 fields · synced Aug 3, 2026
- EUDAMED eb7239ad-85a3-4eb3-8c2c-e7a3542c2b64 61 fields · synced May 17, 2026
- EUDAMED 398c287c-43b8-4559-85cc-2a1910914212 61 fields · synced Jul 9, 2026
- EUDAMED 473acd3a-f1e3-46c0-a325-ac211ab8c9ba 61 fields · synced Aug 3, 2026