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AutoChem GLU Calibrator
EUDAMEDClass C (EU MDR)
Ref 360104GLU0S11Model AutoChem series instrument
Identity
- Trade Name
- AutoChem GLU Calibrator EUDAMED
- Device Name
- AutoChem GLU EUDAMED
- Model / Reference
- AutoChem series instrument EUDAMED360104GLU0S11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942253020258 EUDAMED
- Basic UDI-DI
- 69422530000049NU EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
AutoChem GLU Calibrator by Autobio Biochemistry Co., Ltd — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69422530000049NU | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Biochemistry Co., Ltd
- EUDAMED SRN
- CN-MF-000038143
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 428b9bba-ae5e-4d2f-8a13-415ba8cd5747 61 fields · synced Jun 20, 2026