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Corin BiPolar-i 2110001

by Corin Ltd

Ref 2110001Model Bipolar Instrument Set

Corin BiPolar-i 2110001 is a device classified as Class I in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-05056139233838), cleared under FDA 510(k) K183114 on 5 Jun 2019 and listed in FDA GUDID since 25 Jul 2019 (UDI-DI 05056139233838), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183114

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056139233838 Basic UDI-DI 05056139233838UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139233838 UDI-DI Date25 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183114 Date5 Jun 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05056139233838 registered 23 Oct 2026 Active
  • FDA 510(k) K183114 decided 5 Jun 2019 Active
  • FDA GUDID UDI-DI 05056139233838 listed 25 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183114
  2. Listed FDA GUDID 05056139233838
  3. Registered EUDAMED B-05056139233838

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Trial Introducer Handle EUDAMED
Corin BiPolar-i GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / reference
2110001, Bipolar Instrument Set
Primary DI / UDI-DI
05056139233838
Basic UDI-DI
B-05056139233838
510(k) Number
FDA product code
KWY
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3390
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K183114)

and 8 more cleared under K183114

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)