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Hämoglobin Kontrolle
EUDAMEDClass IVD General (EU MDR)
Ref HEM QSModel Diaglobal Photometer
Identity
- Trade Name
- Hämoglobin Kontrolle EUDAMED
- Device Name
- DP 350 / DP 550 EUDAMED
- Model / Reference
- Diaglobal Photometer EUDAMEDHEM QS EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-4260152490166ST EUDAMED
- Basic UDI-DI
- B-4260152490166ST EUDAMED
- EMDN Code
- W0103010606 HAEMATOLOGY CONTROLS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Hämoglobin Kontrolle by Diaglobal GmbH — 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-4260152490166ST | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diaglobal GmbH
- EUDAMED SRN
- DE-MF-000032608
Sources (1)
- EUDAMED 2b93f78c-f085-4add-81b5-322becc15186 61 fields · synced Jun 20, 2026