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HbA1c Assay kit CLIA
EUDAMEDClass IVD General (EU MDR)
Ref SUPM081072Ref SUPM081036
Identity
- Trade Name
- HbA1c Assay kit CLIA EUDAMED
- Device Name
- HbA1c Assay kit CLIA EUDAMED
- Model / Reference
- SUPM081072 EUDAMEDSUPM081036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001485 EUDAMED06974521001478 EUDAMED
- Basic UDI-DI
- B-06974521001485 EUDAMEDB-06974521001478 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA1c Assay kit CLIA by Shenzhen Superbio Technology Co., Ltd. — 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-06974521001485 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 97ac07c1-d5b8-4114-8fbf-5c19b4511b5b 61 fields · synced Jun 20, 2026
- EUDAMED c05df673-0c8c-4486-a921-db6119e82109 61 fields · synced May 16, 2026