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Glycated Hemoglobin A1c Control
EUDAMEDClass IVD General (EU MDR)
Ref ZK420Y1Model 2×0.5mL
Identity
- Trade Name
- Glycated Hemoglobin A1c Control EUDAMED
- Device Name
- Glycated Hemoglobin A1c Control EUDAMED
- Model / Reference
- 2×0.5mL EUDAMEDZK420Y1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595705980 EUDAMED
- Basic UDI-DI
- B-06936595705980 EUDAMED
- EMDN Code
- W0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glycated Hemoglobin A1c Control by Medicalsystem Biotechnology 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-06936595705980 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e7319d44-5cef-4be0-a4c8-9b8dea7bd49f 61 fields · synced Jun 18, 2026