Skip to content

4170502

by Richard Wolf GmbH

Ref 4170502Model 10000201218

4170502 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 8 Sep 2026 (Basic UDI-DI B-04055207054116) and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 04055207054116), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207054116 Basic UDI-DI 04055207054116UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207054116 UDI-DI Date28 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207054116 registered 8 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207054116 listed 28 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207054116
  2. Registered EUDAMED B-04055207054116

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  • Withdrawn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
Endoscopic insufflation tubing set, single-use
Device name
Sterile insufflation tube sets
Model / Ref / Catalog
4170502, 10000201218
Primary DI / UDI-DI
04055207054116
Basic UDI-DI
B-04055207054116
FDA product code
HIF
EMDN code
Z12029014 Gas pre–heating units
GMDN term
Endoscopic insufflation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1730
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 3 Meter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Endoscopic insufflation tubing set, single-use

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)