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4170801

by Richard Wolf GmbH

Ref 4170.801Model 10000201222

4170801 (4170.801) 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-04055207048580) and listed in FDA GUDID since 19 Aug 2020 (UDI-DI 04055207048580), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207048580 Basic UDI-DI 04055207048580UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207048580 UDI-DI Date19 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207048580 registered 8 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207048580 listed 19 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207048580
  2. Registered EUDAMED B-04055207048580

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  • Withdrawn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
Surgical irrigation/aspiration tubing set
Device name
Insufflation tube sets
Model / Ref / Catalog
10000201222, 4170.801, 4170801
Primary DI / UDI-DI
04055207048580
Basic UDI-DI
B-04055207048580
FDA product code
HIF
EMDN code
A060102 Surgical drainage connection medical tubes
GMDN term
Surgical irrigation/aspiration tubing set
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201222
4170.801
GUDID
4170801
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: Surgical irrigation/aspiration tubing set

Similar devices in this category

Other devices filed under SURGICAL DRAINAGE CONNECTION MEDICAL TUBES.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)