Identity
- Trade Name
- VIVA RF Generator EUDAMED
- Device Name
- VIVA RF Generator EUDAMED
- Model / Reference
- VRS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306769183 EUDAMED
- Basic UDI-DI
- B-08809306769183 EUDAMED880930676VIVARF_GR4 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Foot-switch, electrical
VIVA RF Generator 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-08809306769183 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306769183 | 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 3ed8b2c4-3b88-408d-8ad6-a402e474e11a 61 fields · synced Jul 21, 2026
- EUDAMED 6747ddef-30a1-45ba-8127-4c249b02ee59 61 fields · synced May 19, 2026