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8394506

by Richard Wolf GmbH

Ref 8394.506Model 10000201268

8394506 (8394.506) is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04055207016589) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 04055207016589), 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-04055207016589 Basic UDI-DI 04055207016589UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207016589 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207016589 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207016589 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207016589
  2. Registered EUDAMED B-04055207016589

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  • Withdrawn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
Suturing needle holder, reusable
Device name
Modular needle holder inserts
Model / Ref / Catalog
10000201268, 8394.506, 8394506
Description
NEEDLE HOLDER INSERT WITH SHEATH Ø 5MM by Sarbu, WL 415mm, with irrigation connection, reusable
Primary DI / UDI-DI
04055207016589
Basic UDI-DI
B-04055207016589
FDA product code
FHQ
EMDN code
L1205 Laparoscopic and thoracoscopic surgery needle holders, reusable
GMDN term
Suturing needle holder, reusable
Device class
Class I
Regulation number
876.4730
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 — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201268
8394.506
GUDID
8394506

Related devices

Category: Suturing needle holder, reusable

Similar devices in this category

Other devices filed under LAPAROSCOPIC AND THORACOSCOPIC SURGERY NEEDLE HOLDERS, 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)