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Ellisys Plus
EUDAMEDClass IIb (EU MDR)
Ref CWM-930MRef [EM 007(930M)_R3] CWM-930M User manual
Identity
- Trade Name
- ELLISYS PLUS EUDAMEDChungwoo Co., Ltd. EUDAMED
- Model / Reference
- CWM-930M EUDAMED[EM 007(930M)_R3] CWM-930M User manual EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809495930364 EUDAMED
- Basic UDI-DI
- 880949593930QF EUDAMEDB-08809495930364 EUDAMED
- Direct Marketing DI
- 08809495930364 EUDAMED
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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 Plus by Chungwoo Co., Ltd. — Class IIb — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880949593930QF | Class IIb | Active |
| 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 (2)
- EUDAMED 2e7b652c-88ac-4c21-9be6-7d6349c05ec2 61 fields · synced Jul 13, 2026
- EUDAMED f4592fe0-8d98-4e71-92b4-c459c9998e17 61 fields · synced May 17, 2026