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HemoTrol Low (Level 1)
EUDAMEDClass IVD General (EU MDR)
Ref 202.001.002Ref 022.001.002
Identity
- Trade Name
- HemoTrol Low (Level 1) EUDAMED
- Device Name
- HemoTrol Low (Level 1) EUDAMED
- Model / Reference
- 202.001.002 EUDAMED022.001.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-202.001.0025F EUDAMEDD-022.001.0025B EUDAMED
- Basic UDI-DI
- B-202.001.0025F EUDAMEDB-022.001.0025B 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
HemoTrol Low (Level 1) 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-202.001.0025F | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (2)
- EUDAMED 23298ccf-ab2f-4cb2-b298-f8f989e7c456 61 fields · synced Jul 22, 2026
- EUDAMED bfa2663d-15c8-450e-ad61-1489ed10ff3e 61 fields · synced May 18, 2026