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Glycated Hemoglobin A1c Control
EUDAMEDClass IVD General (EU MDR)
Ref ZK411BYModel 1×1mL
Identity
- Trade Name
- Glycated Hemoglobin A1c Control EUDAMED
- Device Name
- Glycated Hemoglobin A1c Control EUDAMED
- Model / Reference
- 1×1mL EUDAMEDZK411BY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970291983433 EUDAMED
- Basic UDI-DI
- B-06970291983433 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-06970291983433 | 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 36aa7e9f-2573-4f85-8f48-3abca72c3275 61 fields · synced Jun 18, 2026