Identity
- Trade Name
- ELLISYS SENSE EUDAMED
- Model / Reference
- CWM-930M EUDAMEDCWM-930S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809495930753 EUDAMED
- Basic UDI-DI
- 880949593930QF EUDAMED
- Direct Marketing DI
- 08809495930753 EUDAMED
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Latvia EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Radio-frequency ablation system
Ellisys Sense by Chungwoo Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 880949593930QF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chungwoo Co., Ltd.
- EUDAMED SRN
- KR-MF-000017583
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 5fdd34b7-b39d-4df4-887c-1a863ee1d3d0 61 fields · synced Jul 29, 2026