Identity
- Trade Name
- CueSee HbA1c - Level 1 EUDAMED
- Device Name
- CueSee HbA1c - Level 1 EUDAMED
- Model / Reference
- 011.001.010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-011.001.0103N EUDAMED
- Basic UDI-DI
- B-011.001.0103N 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 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-011.001.0103N | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (1)
- EUDAMED 887f84b6-82ef-43fe-9c9a-408353f81ecf 61 fields · synced Jun 18, 2026