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Wullstein retractor 10-420-16

by Spiggle & Theis Medizintechnik GmbH

Ref 10-420-16

Wullstein retractor 10-420-16 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250676729538) and listed in FDA GUDID since 9 Sep 2022 (UDI-DI 04250676729538), 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-04250676729538 Basic UDI-DI 04250676729538UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676729538 UDI-DI Date9 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250676729538 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250676729538 listed 9 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250676729538
  2. Registered EUDAMED B-04250676729538

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  • Withdrawn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
Wullstein retractor
Generic name
Hand-held surgical retractor, reusable
Device name
Retractors
Model / Ref / Catalog
10-420-16
Description
3:3 prongs, semi-sharp, dismountable 16 cm
Primary DI / UDI-DI
04250676729538
Basic UDI-DI
B-04250676729538
FDA product code
GAD
EMDN code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN term
Hand-held surgical retractor, 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: Hand-held surgical retractor, reusable

Similar devices in this category

Other devices filed under SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER.

Other devices from Spiggle & Theis Medizintechnik GmbH

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)