Identity
- Trade Name
- EXTEL HEMO・AUTO HS Calibrator EUDAMED
- Device Name
- EXTEL HEMO・AUTO HS Latex EUDAMED
- Model / Reference
- 65556 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987295655565 EUDAMED
- Basic UDI-DI
- 4987295BU001ZR EUDAMED
- EMDN Code
- W0102152205 TUMOUR MARKER STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
EXTEL HEMO・AUTO HS Calibrator by Canon Medical Diagnostics Corporation — 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 | 4987295BU001ZR | Class C | Active |
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Manufacturer
- Manufacturer
- Canon Medical Diagnostics Corporation
- EUDAMED SRN
- JP-MF-000020364
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b09ab592-6829-48fd-8ea1-c688f60c68d7 61 fields · synced Jun 17, 2026