Identity
- Trade Name
- Glucose EUDAMED
- Device Name
- Glucose EUDAMED
- Model / Reference
- HBL04(A,M) EUDAMEDHBL04M EUDAMEDHBL04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100578 EUDAMED05404035100561 EUDAMED
- Basic UDI-DI
- 54040351HBL046P EUDAMED
- Direct Marketing DI
- 05404035100578 EUDAMED05404035100561 EUDAMED
- EMDN Code
- W01010213 GLUCOSE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
Glucose by Cypress Diagnostics — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 54040351HBL046P | Class B | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (2)
- EUDAMED 9691be8d-d8af-4c7b-ba6c-02b5c90fba15 61 fields · synced Jul 22, 2026
- EUDAMED 2b49201f-695e-4829-a45b-322578e72cd0 61 fields · synced May 18, 2026