Identity
- Trade Name
- Wireless-CAM EUDAMED
- Device Name
- Wireless-CAM EUDAMED
- Model / Reference
- CW-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800138500364 EUDAMED
- Basic UDI-DI
- 08800138CW-2000UY EUDAMED
- EMDN Code
- Z12020402,Z12021004,Z12021005,Z12021006,Z12021009,Z12021080 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wireless-CAM by M.I.ONE Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08800138CW-2000UY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- M.I.ONE Co., Ltd.
- EUDAMED SRN
- KR-MF-000050358
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 9b0b0822-1bb9-47cd-a0cb-fc850a3ae5a1 61 fields · synced Jul 15, 2026