Identity
- Trade Name
- VIVA RF electrode EUDAMED
- Device Name
- VIVA RF electrode EUDAMED
- Model / Reference
- 18-08V15-40X_V2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306762443 EUDAMED
- Basic UDI-DI
- B-08809306762443 EUDAMED880930676VIVA_EWD EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDBulgaria 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: Open-surgery electrosurgical electrode, monopolar, single-use
VIVA RF electrode by Starmed Co., Ltd — Class IIb — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306762443 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306762443 | Class IIb | Active |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9a67647b-4a1c-4088-ac5e-f08e4c584a78 61 fields · synced Jul 28, 2026
- EUDAMED 0c741b63-7d41-4285-b8a6-cbfae5f8d62b 61 fields · synced May 18, 2026