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892209304

by Richard Wolf GmbH

Ref 892209304Model 10000328144

892209304 is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04055207063019) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 04055207063019), 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-04055207063019 Basic UDI-DI 04055207063019UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207063019 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207063019 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207063019 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207063019
  2. Registered EUDAMED B-04055207063019

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  • Withdrawn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
Spinal surgery working sleeves
Model / Ref / Catalog
892209304, 10000328144
Description
WORKING SLEEVE OD 4MM WL 195MM for bones, graduated
Primary DI / UDI-DI
04055207063019
Basic UDI-DI
B-04055207063019
FDA product code
NBH
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Endoscope sheath, reusable
Device class
Class I
Regulation number
888.1100
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 — 4 Millimeter
Length — 165 Millimeter
Lumen/Inner Diameter — 3 Millimeter

Related devices

Category: Endoscope sheath, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)