VIVA RF electrode
by STARMED Co., Ltd. South Korea EUDAMED
Ref 15-10V15-40X_V2 EMDN K0201010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberKR24/00000016 | Date28 Apr 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08809306763402 | Date7 Sep 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- KR24/00000016 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 28 Apr 2026
- Expires
- 21 Feb 2029
- Reason
- Change approved
Specification
- Model / Reference
- 15-10V15-40X_V2
- Primary DI / UDI-DI
- 08809306763402
- Basic UDI-DI
- B-08809306763402, 880930676VIVA_EWD
- EMDN Code
- K0201010301 Open electrosurgery electrodes, single-use
- Device Class
- Class IIb
- Market of Registration
- FranceBulgaria
Manufacturer details
- EUDAMED SRN
- KR-MF-000008605
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Starmed Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED a290faf0-474d-4ed0-a8ae-9973fc152203
- EUDAMED 08809306763402|880930676VIVA_EWD