Identity
- Trade Name
- Glucose (HK) EUDAMED
- Device Name
- Glucose (HK) EUDAMED
- Model / Reference
- 981304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153813047 EUDAMED
- Basic UDI-DI
- 6438153BU00056BU EUDAMEDB-16438153813047 EUDAMED
- Direct Marketing DI
- 16438153813047 EUDAMED
- EMDN Code
- W01010213 GLUCOSE EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Glucose (HK) by Thermo Fisher Scientific Oy — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438153BU00056BU | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00056BU | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED e7e1cf89-05ee-4e16-a320-4caa0eb2d5a7 61 fields · synced Oct 6, 2026
- EUDAMED 915f5140-efce-4dab-9d1f-dd35e00cddd5 61 fields · synced May 19, 2026