Identity
- Trade Name
- Micro-Dx™ CE IVD EUDAMED
- Device Name
- Micro-Dx™ CE IVD EUDAMED
- Model / Reference
- U-200-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-U-200-04848 EUDAMED
- Basic UDI-DI
- B-U-200-04848 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
Micro-Dx™ 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-200-04848 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Molzym GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000037419
Sources (2)
- EUDAMED a1fa85db-3714-4477-aa48-7fb39e611aa3 61 fields · synced Jul 19, 2026
- EUDAMED 4bb81c93-38ba-4376-8bc4-250a1313ac6d 61 fields · synced Jul 19, 2026