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GlucoTrol-NG Level 5
EUDAMEDClass IVD General (EU MDR)
Ref 146.005.002Ref 155.005.002
Identity
- Trade Name
- GlucoTrol-NG Level 5 EUDAMED
- Device Name
- GlucoTrol-NG Level 5 EUDAMED
- Model / Reference
- 146.005.002 EUDAMED155.005.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-146.005.002CC EUDAMEDD-155.005.002CJ EUDAMED
- Basic UDI-DI
- B-146.005.002CC EUDAMEDB-155.005.002CJ EUDAMED
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - OTHER 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
GlucoTrol-NG Level 5 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-146.005.002CC | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (2)
- EUDAMED e4b4620f-9305-4299-889d-eb22fdd73bb0 61 fields · synced Jul 18, 2026
- EUDAMED d96d1b28-f7ee-4e77-8023-697814034e00 61 fields · synced May 18, 2026