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8391501

by Richard Wolf GmbH

Ref 8391.501Model 10000201497

8391501 (8391.501) is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-04055207062401) and listed in FDA GUDID since 21 Jul 2017 (UDI-DI 04055207062401), 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-04055207062401 Basic UDI-DI 04055207062401UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207062401 UDI-DI Date21 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207062401 registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207062401 listed 21 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207062401
  2. Registered EUDAMED B-04055207062401

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  • Withdrawn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
Needle holders
Model / Ref / Catalog
10000201497, 8391.501, 8391501
Description
NEEDLE HOLDER Ø 3.5MM BNDL 2 part, SL 340mm
Primary DI / UDI-DI
04055207062401
Basic UDI-DI
B-04055207062401
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 — 3.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201497
8391.501
GUDID
8391501

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
  • Manufacturing date
Other properties (21, all answered No)