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88405131

by Richard Wolf GmbH

Ref 88405131Model 10000201298

88405131 is a device classified as Class IIa in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04055207028612) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207028612), 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-04055207028612 Basic UDI-DI 04055207028612UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207028612 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207028612 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207028612 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207028612
  2. Registered EUDAMED B-04055207028612

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  • Withdrawn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

Generic name
Endoscope sheath, reusable
Device name
Transanal Endoscopic Microsurgery
Model / Ref / Catalog
88405131, 10000201298
Description
INNER TUBE TEM Ø 11.5MM WL 282MM WL 282mm, for 88045132 in combination with 10mm telescopes 8934432 (30°) and 8934433 (50°), reusable
Primary DI / UDI-DI
04055207028612
Basic UDI-DI
B-04055207028612
FDA product code
GCM
EMDN code
L0406 Rigid rectoscopes and anoscopes, reusable
GMDN term
Endoscope sheath, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
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
Size
Outer Diameter — 11.5 Millimeter
Length — 282 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Endoscope sheath, reusable

Similar devices in this category

Other devices filed under ABDOMINAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)