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8436511

by Richard Wolf GmbH

Ref 8436.511Model 10000201144

8436511 (8436.511) is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-04055207042496) and listed in FDA GUDID since 3 Aug 2022 (UDI-DI 04055207042496), 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-04055207042496 Basic UDI-DI 04055207042496UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207042496 UDI-DI Date3 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207042496 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207042496 listed 3 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207042496
  2. Registered EUDAMED B-04055207042496

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  • Withdrawn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
Bone file/rasp, manual, reusable
Device name
Arthroscopic files and rasps
Model / Ref / Catalog
10000201144, 8436.511, 8436511
Description
CONVEX CARTILAGE FILE WL 125MM W 6.25MM rough, reusable
Primary DI / UDI-DI
04055207042496
Basic UDI-DI
B-04055207042496
FDA product code
NBH
EMDN code
L1920 Arthroscopic surgery files and rasps, reusable
GMDN term
Bone file/rasp, manual, 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
Width — 6.25 Millimeter
Length — 125 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201144
8436.511
GUDID
8436511

Related devices

Category: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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