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8383611

by Richard Wolf GmbH

Ref 8383.611Model 10000201227

8383611 (8383.611) 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-04055207015100) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207015100), 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-04055207015100 Basic UDI-DI 04055207015100UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207015100 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207015100 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207015100 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207015100
  2. Registered EUDAMED B-04055207015100

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  • Withdrawn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
Myoma screw, reusable
Device name
Gynecological myoma drills
Model / Ref / Catalog
10000201227, 8383.611, 8383611
Description
MYOMA DRILL Ø 5MM WL 320MM rigid, TL 400mm, reusable
Primary DI / UDI-DI
04055207015100
Basic UDI-DI
B-04055207015100
FDA product code
HET
EMDN code
L059099 Obstetrics and gynecology instruments, reusable - other
GMDN term
Myoma screw, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.1720
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 — 320 Millimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201227
8383.611
GUDID
8383611
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: Myoma screw, reusable

Similar devices in this category

Other devices filed under OBSTETRICS AND GYNECOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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