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Surgical Trocar

by Henke-Sass, Wolf GmbH 19 variants

Ref 8300055826

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403587312030105AN Basic UDI-DI 04035873069409UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04035873069409 UDI-DI Date1 May 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Surgical Trocar EUDAMED
Cleaning sheath for Ø3.1mm X 170mm 45° GUDID
Generic Name
Endoscope sheath, reusable
Device Name
Accessories Sinuscopy
Model / Ref / Catalog
8300055826
Primary DI / UDI-DI
04035873069409
Basic UDI-DI
403587312030105AN
Direct Marketing DI
04035873069409
FDA Product Code
KMA
EMDN Code
L031280 Surgical trocar, reusable - accessories
GMDN Term
Endoscope sheath, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.5550
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005531

Other devices from Henke-Sass, Wolf GmbH

See all devices from Henke-Sass, Wolf GmbH →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No