STARwave Generator
Ref SMW10
STARwave Generator (SMW10) is a Class IIb device made by Starmed Co., Ltd, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 880930676STARwave_G9U) with CE/MDR certificate KR24/00000016 valid until 21 Feb 2029, active as of 22 Oct 2026.
Active
CE MDR
Valid until
21 Feb 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880930676STARwave_G9U 08809306769299 | Date20 May 2026 | StatusActive |
Official records
- EUDAMED public site 880930676STARwave_G9U
Certificates
- KR24/00000016 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 28 Apr 2026
- Expires
- 21 Feb 2029
- Reason
- Change approved
Timeline
- Certificate issued EUDAMED KR24/00000016
- Registered EUDAMED 880930676STARwave_G9U
- Certificate expires EUDAMED KR24/00000016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- SMW10
- Primary DI / UDI-DI
- 08809306769299
- Basic UDI-DI
- 880930676STARwave_G9U
- EMDN code
- Z12010902 Electrosurgical units (esu) for general use
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- KR-MF-000008605
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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