Identity
- Trade Name
- Plasma/Low Hb Control '1.0' EUDAMED
- Device Name
- Plasma/Low Hb Control '1.0' EUDAMED
- Model / Reference
- 053.001.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-053.001.0028R EUDAMED
- Basic UDI-DI
- B-053.001.0028R EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Plasma/Low Hb Control '1.0' by Eurotrol B.V. — 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-053.001.0028R | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (1)
- EUDAMED f2e5de6e-0368-411b-9060-e820012ed14c 61 fields · synced Jun 19, 2026