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Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chro…
EUDAMEDClass IVD General (EU MDR)
Ref 1P001
Identity
- Device Name
- Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chromatography) EUDAMED
- Model / Reference
- 1P001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-02B0015YN EUDAMED
- Basic UDI-DI
- B-02B0015YN EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chro… by Changsha Sinocare Inc. — Class IVD General — IVDD — listed in EUDAMED
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-02B0015YN | 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 e30cc74d-b16a-4a64-99bb-a8aacf79ffe0 61 fields · synced Jul 18, 2026