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Pangea 541400S

by Stryker GmbH

Ref 541400SModel 08858251028222U6

Pangea 541400S is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 08858251028222U6) and listed in FDA GUDID since 1 Mar 2024 (UDI-DI 07613327603408), active as of 12 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028222U6 Basic UDI-DI 07613327603408UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327603408 UDI-DI Date1 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028222U6 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327603408 listed 1 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327603408
  2. Registered EUDAMED 08858251028222U6

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Pangea
Generic name
Orthopaedic bone cerclage wire
Model / Ref / Catalog
541400S, 08858251028222U6
Primary DI / UDI-DI
07613327603408
Basic UDI-DI
08858251028222U6
FDA product code
HWC
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic bone cerclage wire
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Orthopaedic bone screw (non-sliding)

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)