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838394

by Richard Wolf GmbH

Ref 8383.94Model 10000201391

838394 (8383.94) 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 5 Oct 2026 (Basic UDI-DI B-04055207040140) and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 04055207040140), 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-04055207040140 Basic UDI-DI 04055207040140UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207040140 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207040140 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207040140 listed 28 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207040140
  2. Registered EUDAMED B-04055207040140

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  • Withdrawn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 handpiece, reusable
Device name
Rigid suction irrigation/suction tubes
Model / Ref / Catalog
10000201391, 8383.94, 838394
Description
SUCT./IRRIG. TUBE Ø 5MM WL 300MM reusable
Primary DI / UDI-DI
04055207040140
Basic UDI-DI
B-04055207040140
FDA product code
JOL
EMDN code
L030101 Suction and irrigation surgical cannulas and handpieces, reusable
GMDN term
Surgical irrigation/aspiration handpiece, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6740
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 — 300 Millimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201391
8383.94
GUDID
838394
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 handpiece, reusable

Similar devices in this category

Other devices filed under SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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