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VIVA RF Generator

by STARMED Co., Ltd.

Ref VRS01

VIVA RF Generator (VRS01) is a medical device (EU MDD Class IIb; EMDN category electrosurgical units (esu) for general use) made by Starmed Co., Ltd, registered in EUDAMED on 29 Feb 2024 (Basic UDI-DI B-08809306769183) with CE/MDR certificate KR24/00000016 valid until 21 Feb 2029, active as of 24 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

21 Feb 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberKR24/00000016 Date28 Apr 2026IssuedStatusActive expires 21 Feb 2029
European UnionCE/MDD NumberB-08809306769183 Basic UDI-DI 08809306769183UDI-DIDate29 Feb 2024RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR24/00000016 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    28 Apr 2026
    Expires
    21 Feb 2029
    Reason
    Change approved

Timeline

3 dated events

  1. Registered EUDAMED B-08809306769183
  2. Certificate issued EUDAMED KR24/00000016
  3. Certificate expires EUDAMED KR24/00000016

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / reference
VRS01
Primary DI / UDI-DI
08809306769183
Basic UDI-DI
B-08809306769183, 880930676VIVARF_GR4
EMDN code
Z12010902 Electrosurgical units (esu) for general use
Device class
Class IIb
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
KR-MF-000008605
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Foot-switch, electrical

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Starmed Co., Ltd

See all devices from Starmed Co., Ltd →

Properties

  • Reusable
  • Measuring function
Other properties (12, all answered No)