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Glycated Hemoglobin A1c Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref JZ420YModel 2×0.5mLRef JZ411TYModel 5×1mL
Identity
- Trade Name
- Glycated Hemoglobin A1c Calibrator EUDAMED
- Device Name
- Glycated Hemoglobin A1c Calibrator EUDAMED
- Model / Reference
- 2×0.5mL EUDAMEDJZ420Y EUDAMED5×1mL EUDAMEDJZ411TY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750386 EUDAMED06970291983426 EUDAMED
- Basic UDI-DI
- B-06936595750386 EUDAMEDB-06970291983426 EUDAMED
- EMDN Code
- W0102152208 STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS 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 Calibrator 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-06936595750386 | 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 (2)
- EUDAMED c3fb88db-55bc-4a0c-804c-baf7857b1351 61 fields · synced Jul 12, 2026
- EUDAMED 5bee3333-818f-4003-9f1e-80aa1a38391b 61 fields · synced May 19, 2026