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15360021

by Richard Wolf GmbH

Ref 15360021Model 10000201071

15360021 is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI B-04055207066645) and listed in FDA GUDID since 12 Aug 2022 (UDI-DI 04055207066645), 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-04055207066645 Basic UDI-DI 04055207066645UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207066645 UDI-DI Date12 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207066645 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207066645 listed 12 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207066645
  2. Registered EUDAMED B-04055207066645

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  • Withdrawn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
15360021, 10000201071
Primary DI / UDI-DI
04055207066645
Basic UDI-DI
B-04055207066645
FDA product code
NBH
EMDN code
L0925 Orthopaedic surgery dilators, reusable
GMDN term
Endoscopic-access dilator, 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

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