← Back to catalogue
OC-Light™ S FIT Test Strips
EUDAMEDClass C (EU MDR)
Ref V-PC52Model OC-Light™ S FIT Test Strips
Identity
- Trade Name
- OC-Light™ S FIT Test Strips EUDAMED
- Model / Reference
- OC-Light™ S FIT Test Strips EUDAMEDV-PC52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987026207339 EUDAMED
- Basic UDI-DI
- 4987026TD-OCLSZW EUDAMED
- EMDN Code
- W0102039013 FECAL OCCULT BLOOD (IC) 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-Light™ S FIT Test Strips 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-OCLSZW | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eiken Chemical Co., Ltd.
- EUDAMED SRN
- JP-MF-000018097
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 2d0e912e-7687-4edc-a256-06eb62a96640 61 fields · synced Jun 18, 2026