Identity
- Trade Name
- Glucose (HK) EUDAMEDFDA UDI
- Generic Name
- Glucose IVD, kit, spectrophotometry FDA UDI
- Device Name
- Glucose (HK) EUDAMEDFor in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers. FDA UDI
- Model / Reference
- 981779 EUDAMEDNONE FDA UDI
- Description
- For in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers. FDA UDI
Identifiers
- Catalog Number
- 981779 FDA UDI
- Primary DI / UDI-DI
- 16438153817793 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16438153817793 EUDAMED6438153BU00056BU EUDAMED
- Direct Marketing DI
- 16438153817793 EUDAMED
- 510(k) Number
- K110035 FDA UDI
- FDA Product Code
- CFR FDA UDI
- EMDN Code
- W01010213 GLUCOSE EUDAMED
- GMDN Term
- Glucose IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Glucose (HK) by Thermo Fisher Scientific Oy — Class IVD General — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-16438153817793 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDR | B-16438153817793 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (3)
- EUDAMED 12c255b5-41b1-468e-a2b6-f20a4688aced 61 fields · synced Oct 6, 2026
- EUDAMED edbd0d34-b4b5-4128-9779-25e75d76884e 61 fields · synced May 17, 2026
- FDA UDI 2cc2a908-554b-4e89-93c3-e6ead88eb4fc 36 fields · synced May 30, 2026