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Bipolar Cable SIEC-JX/B

by Soniquence, LLC

Ref SIEC-JX/B

Bipolar Cable SIEC-JX/B is a device classified as Class I in the EU and Class II in the US made by Soniquence, LLC, registered in EUDAMED on 3 Aug 2025 (Basic UDI-DI 0081002618SIEC-JX/BFY), cleared under FDA 510(k) K211946 on 16 Jul 2021 and listed in FDA GUDID since 19 Sep 2021 (UDI-DI 00810026180507), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211946

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0081002618SIEC-JX/BFY Basic UDI-DI 00810026180507UDI-DIDate3 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810026180507 UDI-DI Date19 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK211946 Date16 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0081002618SIEC-JX/BFY registered 3 Aug 2025 Active
  • FDA 510(k) K211946 decided 16 Jul 2021 Active
  • FDA GUDID UDI-DI 00810026180507 listed 19 Sep 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211946
  2. Listed FDA GUDID 00810026180507
  3. Registered EUDAMED 0081002618SIEC-JX/BFY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bipolar Cable
Generic name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
SIEC-JX/B
Primary DI / UDI-DI
00810026180507
Basic UDI-DI
0081002618SIEC-JX/BFY
510(k) Number
FDA product code
GEI
EMDN code
L181003 Electrosurgery connection cables, reusable
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K211946)

Similar devices in this category

Other devices filed under ELECTROSURGERY CONNECTION CABLES, REUSABLE.

Other devices from Soniquence, LLC

See all devices from Soniquence, LLC →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)