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Bipolar Wand

by Soniquence, LLC 25 variants

Ref SDTF-24Model SDTFQM-40

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

CE MDR

Valid until

12 Feb 2028

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0081002618SDTFQM-40TQ Basic UDI-DI 00810026181221UDI-DIDate11 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810026181221 UDI-DI Date18 Jan 2021ListedStatusListed GUDID: in commercial distribution

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Model / Ref / Catalog
SDTFQM-40, SDTF-24
Primary DI / UDI-DI
00810026181221
Basic UDI-DI
0081002618SDTFQM-40TQ
510(k) Number
FDA Product Code
GEI
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Related devices

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

Other devices from Soniquence, LLC

See all devices from Soniquence, LLC →

Properties

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

Other properties (19)

  • 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
  • Manufacturing Date: No