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89193513

by Richard Wolf GmbH

Ref 8919.3513Model 10000201297

89193513 (8919.3513) is a device classified as Class I 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-04055207028780) and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 04055207028780), 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-04055207028780 Basic UDI-DI 04055207028780UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207028780 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207028780 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207028780 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207028780
  2. Registered EUDAMED B-04055207028780

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  • Withdrawn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 trocar blade, reusable
Device name
Surgical trocar tips
Model / Ref / Catalog
10000201297, 8919.3513, 89193513
Description
TROCAR TIP TRIANGULAR SZ 5.5MM WL 144MM distal tip triangular, reusable
Primary DI / UDI-DI
04055207028780
Basic UDI-DI
B-04055207028780
FDA product code
FBQ
EMDN code
L031299 Surgical trocar, reusable - other
GMDN term
Laparoscopic trocar blade, reusable
Device class
Class I 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 — 144 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201297
8919.3513
GUDID
89193513
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 trocar blade, 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)