Skip to content

Roux retractor 80-318-01

by Spiggle & Theis Medizintechnik GmbH

Ref 80-318-01

Roux retractor 80-318-01 is a hand-held surgical retractor (EU MDD Class I; FDA Class I; FDA product code GAD, Retractor) made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250381890325) and listed in FDA GUDID since 28 Sep 2022 (UDI-DI 04250381890325), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250381890325 Basic UDI-DI 04250381890325UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250381890325 UDI-DI Date28 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250381890325 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250381890325 listed 28 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250381890325
  2. Registered EUDAMED B-04250381890325

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  • Withdrawn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
Roux retractor
Generic name
Hand-held surgical retractor, reusable
Device name
Hooks, Needles, Perforators
Model / Ref / Catalog
80-318-01
Description
double ended 20.8x25 mm and 28.5x30.5 mm, 14.5 cm
Primary DI / UDI-DI
04250381890325
Basic UDI-DI
B-04250381890325
FDA product code
GAD
EMDN code
L03140104 Spreaders hooks, reusable
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 HOOKS, REUSABLE.

Other devices from Spiggle & Theis Medizintechnik GmbH

See all devices from Spiggle & Theis Medizintechnik GmbH →

Properties

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