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Interface Cable Procedure Pack

by Creo Medical

Ref 7-RS2-210

Interface Cable Procedure Pack (7-RS2-210) is an electrical-only medical device connection cable (EU MDR Class I; FDA Class II; FDA product code KNS, Unit, Electrosurgical, Endoscopic (With Or Without Accessories)) made by Creo Medical, registered in EUDAMED on 10 Dec 2024 (Basic UDI-DI 506035956InterfaceCaRS26D), cleared under FDA 510(k) K171983 on 17 Aug 2017 and listed in FDA GUDID since 15 Nov 2018 (UDI-DI 05060359560063), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

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, self-declared

Class I: no certifier involved

510(k) K171983

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 Number506035956InterfaceCaRS26D Basic UDI-DI 05060359560063UDI-DIDate10 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05060359560063 UDI-DI Date15 Nov 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171983 Date17 Aug 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506035956InterfaceCaRS26D registered 10 Dec 2024 Active
  • FDA 510(k) K171983 decided 17 Aug 2017 Active
  • FDA GUDID UDI-DI 05060359560063 listed 15 Nov 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K171983
  2. Listed FDA GUDID 05060359560063
  3. Registered EUDAMED 506035956InterfaceCaRS26D

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  • Withdrawn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
Interface Cable Procedure Pack EUDAMED
Procedure Pack Interface Cable, single use, 1.5 m GUDID
Generic name
Electrical-only medical device connection cable, single-use
Model / Ref / Catalog
7-RS2-210
Primary DI / UDI-DI
05060359560063
Basic UDI-DI
506035956InterfaceCaRS26D
510(k) Number
FDA product code
KNS
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
876.4300
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
Not in Commercial Distribution

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
GB-MF-000019076
Authorised representative
Creo Medical, S.L.U. ES-AR-000001355

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 Creo Medical

See all devices from Creo Medical →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)