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Pectus screwdriver 026-00010

by MedXpert GmbH

Ref 026-00010Model 026-00010 Pectus Schraubendreher

Pectus screwdriver 026-00010 is a Class I device made by MedXpert GmbH, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI B-04260029584714) and listed in FDA GUDID since 30 Jun 2017 (UDI-DI 04260029584714), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260029584714 Basic UDI-DI 04260029584714UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260029584714 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260029584714 registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 04260029584714 listed 30 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260029584714
  2. Registered EUDAMED B-04260029584714

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  • Withdrawn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 System EUDAMED
Pectus screwdriver GUDID
Generic name
Surgical screwdriver, reusable
Device name
026-00010 Pectus Schraubendreher
Model / reference
026-00010, 026-00010 Pectus Schraubendreher
Primary DI / UDI-DI
04260029584714
Basic UDI-DI
B-04260029584714
FDA product code
MDM
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
878.4800
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

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from MedXpert GmbH

See all devices from MedXpert GmbH →

Properties

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