Identity
- Trade Name
- OC-SENSOR Ceres EUDAMED
- Model / Reference
- OC Equipment Family EUDAMEDMV5K00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987026355214 EUDAMED
- Basic UDI-DI
- 4987026TD-OCEQZ5 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
OC-SENSOR Ceres by Eiken Chemical Co., Ltd. — 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 | 4987026TD-OCEQZ5 | Class A | 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 2575e63b-e589-4454-8f17-d5ea93ed4896 61 fields · synced Jul 25, 2026