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Bipolar cable

by Soniquence, LLC 3 variants

Ref SBCD-EU/1Model SIEC-DJX

Bipolar cable (SBCD-EU/1) is a device classified as Class I in the EU and Class II in the US made by Soniquence, LLC, registered in EUDAMED on 19 Feb 2026 (Basic UDI-DI 0081002618SIEC-DJX29), cleared under FDA 510(k) K190336 on 20 Jun 2019 and listed in FDA GUDID since 26 Mar 2021 (UDI-DI 00810026181740), 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) K190336

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-DJX29 Basic UDI-DI 00810026181740UDI-DIDate19 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810026181740 UDI-DI Date26 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190336 Date20 Jun 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0081002618SIEC-DJX29 registered 19 Feb 2026 Active
  • FDA 510(k) K190336 decided 20 Jun 2019 Active
  • FDA GUDID UDI-DI 00810026181740 listed 26 Mar 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190336
  2. Listed FDA GUDID 00810026181740
  3. Registered EUDAMED 0081002618SIEC-DJX29

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  • Withdrawn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

Generic name
Electrical-only medical device connection cable, single-use
Model / Ref / Catalog
SIEC-DJX, SBCD-EU/1
Primary DI / UDI-DI
00810026181740
Basic UDI-DI
0081002618SIEC-DJX29
510(k) Number
FDA product code
GEI
EMDN code
K02010203 Electrosurgery connection cables, single-use
GMDN term
Electrical-only medical device connection cable, single-use
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
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.

Manufacturer details

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

Related devices

Category: Electrical-only medical device connection cable, reusable

Similar devices in this category

Other devices filed under ELECTROSURGERY CONNECTION CABLES, SINGLE-USE.

Other devices from Soniquence, LLC

See all devices from Soniquence, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)