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respons®A1c Hemoglobin A1c Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref 963207
Identity
- Trade Name
- respons®A1c Hemoglobin A1c Test Kit EUDAMED
- Device Name
- respons®A1c Hemoglobin A1c Test Kit EUDAMED
- Model / Reference
- 963207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134660750 EUDAMED
- Basic UDI-DI
- B-08806134660750 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
respons®A1c Hemoglobin A1c Test Kit by GC Medical Science Corporation — 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-08806134660750 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GC Medical Science Corporation
- EUDAMED SRN
- KR-MF-000015840
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED ec3335c4-552d-4b4b-8199-bb1cdf9bcb35 61 fields · synced Jul 30, 2026