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OC-FIT Calibrator (for OC-SENSOR PLEDIA, io)
EUDAMEDClass C (EU MDR)
Ref V-PH52Model OC-SENSOR Reagent Family
Identity
- Trade Name
- OC-FIT Calibrator (for OC-SENSOR PLEDIA, io) EUDAMED
- Model / Reference
- OC-SENSOR Reagent Family EUDAMEDV-PH52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987026182339 EUDAMED
- Basic UDI-DI
- 4987026TD-OCHBYG EUDAMED
- EMDN Code
- W0102152205 TUMOUR MARKER STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
OC-FIT Calibrator (for OC-SENSOR PLEDIA, io) by Eiken Chemical 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 | 4987026TD-OCHBYG | Class C | Active |
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Manufacturer
- Manufacturer
- Eiken Chemical Co., Ltd.
- EUDAMED SRN
- JP-MF-000018097
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 86c46974-4267-426e-a5d3-57002d6d4aa3 61 fields · synced Jun 19, 2026