Ellisys Plus
Ref CWM-930M, [EM 007(930M)_R3] CWM-930M User manualModel CWM-930M, CWM-930S
Ellisys Plus (CWM-930M) is a Class IIb device made by Chungwoo Co., Ltd., registered in EUDAMED on 8 May 2025 (Basic UDI-DI 880949593930QF) with CE/MDR certificate 2025-MDR/QS-026/B valid until 9 Apr 2030, active as of 24 Oct 2026.
Active
CE MDR
Valid until
9 Apr 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-026/B | Date27 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 880949593930QF
Certificates
- 2025-MDR/QS-026/B Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 27 Aug 2026
- Expires
- 9 Apr 2030
- Reason
- Other
Timeline
- Registered EUDAMED 880949593930QF
- Certificate issued EUDAMED 2025-MDR/QS-026/B
- Certificate expires EUDAMED 2025-MDR/QS-026/B
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade name
- Ellisys PlusChungwoo Co., Ltd.
- Device name
- Fractional RF Surgical Unit with Sterile MicroNeedle
- Model / reference
- CWM-930M, CWM-930S, [EM 007(930M)_R3] CWM-930M User manual
- Primary DI / UDI-DI
- 08809495930364
- Basic UDI-DI
- 880949593930QF, B-08809495930364
- Direct marketing DI
- 08809495930364
- EMDN code
- K020380 Devices for surgery with radiofrequency generator, single-use - accessories
- Device class
- Class IIb
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000017583
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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