Identity
- Trade Name
- HM-JACKarcⅡ EUDAMED
- Device Name
- HM-JACKarcⅡ EUDAMED
- Model / Reference
- 65787 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987295657873 EUDAMED
- Basic UDI-DI
- 4987295BU002ZT EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
HM-JACKarcⅡ by Canon Medical Diagnostics Corporation — Class A — 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 | 4987295BU002ZT | Class A | 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 f2131fb6-359c-4313-90f9-ec3b8a8e37ab 61 fields · synced Jul 31, 2026