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892206500

by Richard Wolf GmbH

Ref 892206500Model 10000201071

892206500 is a device classified as Class I in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-04055207060063) and listed in FDA GUDID since 1 Mar 2024 (UDI-DI 04055207060063), 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-04055207060063 Basic UDI-DI 04055207060063UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207060063 UDI-DI Date1 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207060063 registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207060063 listed 1 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207060063
  2. Registered EUDAMED B-04055207060063

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  • Withdrawn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
Endoscopic-access dilator, reusable
Device name
Spinal surgery dilators
Model / Ref / Catalog
892206500, 10000201071
Description
DILATOR BNDL threepart
Primary DI / UDI-DI
04055207060063
Basic UDI-DI
B-04055207060063
FDA product code
HRX
EMDN code
L0925 Orthopaedic surgery dilators, reusable
GMDN term
Endoscopic-access dilator, reusable
Device class
Class I EUDAMED
Class II GUDID
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Endoscopic-access dilator, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY DILATORS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Manufacturing date
Other properties (22, all answered No)