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Corin BiPolar-i 1110961

by Corin Ltd

Ref 1110961Model BiPolar-i

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED NumberB-05056139234521 Basic UDI-DI 05056139234521UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139234521 UDI-DI Date16 Jul 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Bipolar-i Ø61/28mm EUDAMED
Corin BiPolar-i GUDID
Generic Name
Bipolar femoral head outer component, hemiarthroplasty
Device Name
BiPolar-i for use in hip hemiarthroplasty
Model / Ref / Catalog
1110961, BiPolar-i
Primary DI / UDI-DI
05056139234521
Basic UDI-DI
B-05056139234521
510(k) Number
FDA Product Code
KWY
EMDN Code
P090804050102 Metal femoral heads, partial hip replacement
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3390
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K183114)

Show all (12)

Other devices from Corin Ltd

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Properties

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

Other properties (18)

  • 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