Skip to content

VIVA RF Electrode

by STARMED Co., Ltd. 19 variants

Ref 18-07V05-15X_V2

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

21 Feb 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809306764089 UDI-DI Date4 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberKR24/00000016 Date28 Apr 2026IssuedStatusActive expires 21 Feb 2029

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Model / Reference
18-07V05-15X_V2
Primary DI / UDI-DI
08809306764089
Basic UDI-DI
880930676VIVA_EWD
510(k) Number
FDA Product Code
GEI
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
GMDN Term
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Related devices

Category: Open-surgery electrosurgical electrode, monopolar, single-use

Other devices from Starmed Co., Ltd

See all devices from Starmed Co., Ltd →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No