Identity
- Trade Name
- Haemoglobin (Single Reagent) EUDAMED
- Device Name
- Haemoglobin (Single Reagent) EUDAMED
- Model / Reference
- 1172 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G4581172002Z4 EUDAMED
- Basic UDI-DI
- B-G4581172002Z4 EUDAMED
- EMDN Code
- W0102160703 TROPONIN I/T - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Haemoglobin (Single Reagent) by Spectrum for Diagnostic Industries (Joint Stock Company) — Class IVD General — IVDD — listed in EUDAMED
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-G4581172002Z4 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED c2fca140-c38d-4186-bd65-b643891713c7 61 fields · synced Oct 6, 2026