Identity
- Trade Name
- CueSee HbA1c - Level 2 EUDAMED
- Device Name
- CueSee HbA1c - Level 2 EUDAMED
- Model / Reference
- 011.002.010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-011.002.0103Z EUDAMED
- Basic UDI-DI
- B-011.002.0103Z EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
CueSee HbA1c - Level 2 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-011.002.0103Z | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (1)
- EUDAMED a2f5fd73-4c47-4534-b6e2-06c1b215862c 61 fields · synced Jun 18, 2026