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Glycated Hemoglobin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2023E-150Ref S2023E-75Ref S2023E-100
Identity
- Device Name
- Glycated Hemoglobin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2023E-150 EUDAMEDS2023E-75 EUDAMEDS2023E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737648 EUDAMED06955792737624 EUDAMED06955792737631 EUDAMED
- Basic UDI-DI
- B-06955792737648 EUDAMEDB-06955792737624 EUDAMEDB-06955792737631 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Glycated Hemoglobin Chemiluminescence Immunoassay Kit by Sansure Biotech 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-06955792737648 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 26c79205-20c7-4902-9200-4a39fef6bf60 61 fields · synced Jul 26, 2026
- EUDAMED 8130b43c-33db-42e8-9a4e-37c34e94e0ca 61 fields · synced May 16, 2026
- EUDAMED fd7bb88a-85b4-4ac3-ad00-e3e0604d1a80 61 fields · synced May 18, 2026