Identity
- Trade Name
- Sinocare EUDAMED
- Device Name
- Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chromatography) EUDAMED
- Model / Reference
- 12600153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175001385 EUDAMED
- Basic UDI-DI
- B-06934175001385 EUDAMED
- EMDN Code
- W0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMED
Classification
- Device Class
- Class IVD General 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sinocare by Changsha Sinocare 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-06934175001385 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 641c9119-8ca6-49ff-ac77-e3462d2782d2 61 fields · synced Jun 9, 2026