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Pectus Locking-Screw, Universal 025-02010

by MedXpert GmbH

Ref 025-02010

Pectus Locking-Screw, Universal 025-02010 is a device classified as Class IIb in the EU and Class II in the US made by MedXpert GmbH, registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI B-04260029584271) and listed in FDA GUDID since 30 Jun 2017 (UDI-DI 04260029584271), active as of 25 Oct 2026.

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

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260029584271 Basic UDI-DI 04260029584271UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260029584271 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260029584271 registered 5 Aug 2026 Active
  • FDA GUDID UDI-DI 04260029584271 listed 30 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260029584271
  2. Registered EUDAMED B-04260029584271

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  • Withdrawn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
Pes EUDAMED
Pectus Locking-Screw, Universal GUDID
Generic name
Rib/rib cage internal fixation/bracing system bracing bar
Device name
025-02010 Pectus Verschluss-Schraube, Universal
Model / reference
025-02010
Primary DI / UDI-DI
04260029584271
Basic UDI-DI
B-04260029584271
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Rib/rib cage internal fixation/bracing system bracing bar
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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 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: Rib/rib cage internal fixation/bracing system bracing bar

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from MedXpert GmbH

See all devices from MedXpert GmbH →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Reprocessed single-use device
  • Prescription use
  • Lot / batch number
Other properties (17, all answered No)