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891301

by Richard Wolf GmbH

Ref 8913.01Model 10000201301

891301 (8913.01) is a device classified as Class IIa in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04055207011515) and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 04055207011515), 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-04055207011515 Basic UDI-DI 04055207011515UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207011515 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207011515 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207011515 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207011515
  2. Registered EUDAMED B-04055207011515

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  • Withdrawn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
Laparoscopic access cannula, reusable
Device name
Surgical and thoracic surgical sheaths
Model / Ref / Catalog
10000201301, 8913.01, 891301
Primary DI / UDI-DI
04055207011515
Basic UDI-DI
B-04055207011515
FDA product code
FBQ
EMDN code
L031299 Surgical trocar, reusable - other
GMDN term
Laparoscopic access cannula, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5090
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
Length — 74 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201301
8913.01
GUDID
891301
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Laparoscopic access cannula, reusable

Similar devices in this category

Other devices filed under SURGICAL TROCAR, REUSABLE - OTHER.

Other devices from Richard Wolf GmbH

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)