Identity
- Trade Name
- Omlipo HbA1c Kit EUDAMED
- Device Name
- Omlipo HbA1c Kit EUDAMED
- Model / Reference
- OP71050 EUDAMEDOP72050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971225931896 EUDAMED06971225932213 EUDAMED
- Basic UDI-DI
- B-06971225931896 EUDAMEDB-06971225932213 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Omlipo HbA1c Kit by Goldsite Diagnostics Inc. — 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-06971225931896 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Goldsite Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000001353
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED b4642b8f-43e3-42a3-8fd4-d5b20272c7b1 61 fields · synced Aug 4, 2026
- EUDAMED 9a96330e-a050-4ea4-9f70-33cde8669b3a 61 fields · synced May 18, 2026