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Bipolar Forceps

by Soniquence, LLC 9 variants

Ref SBF-A1Model SDTFQM-40

Active European Union

CE MDR

Valid until

12 Feb 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081002618SDTFQM-40TQ Basic UDI-DI 00810026184093UDI-DIDate11 Aug 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620156587-01 Active Supplemented

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    16 Jun 2025
    Expires
    12 Feb 2028
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Bipolar Wand
Model / Reference
SDTFQM-40, SBF-A1
Primary DI / UDI-DI
00810026184093
Basic UDI-DI
0081002618SDTFQM-40TQ
EMDN Code
L180401 Open electrosurgery forceps, reusable
Device Class
Class IIb
EU market of registration
Croatia

Manufacturer details

EUDAMED SRN
US-MF-000029810
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Soniquence, LLC

See all devices from Soniquence, LLC →

Properties

Other properties (13)

  • Sterile: No
  • 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