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837800

by Richard Wolf GmbH

Ref 8378.00Model 10000201199

837800 (8378.00) 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 1 Sep 2026 (Basic UDI-DI B-04055207040003) and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 04055207040003), 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-04055207040003 Basic UDI-DI 04055207040003UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207040003 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207040003 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207040003 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207040003
  2. Registered EUDAMED B-04055207040003

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  • Withdrawn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
Uterine probe
Device name
Gynecological intrauterine probes
Model / Ref / Catalog
10000201199, 8378.00, 837800
Description
INTRAUTERINE PROBE Ø 32MM WL 32MM by Cohen, for introduction of fluid for hysterosalpingography, TL 330mm, with Luer connection, reusable
Primary DI / UDI-DI
04055207040003
Basic UDI-DI
B-04055207040003
FDA product code
HHI
EMDN code
L059099 Obstetrics and gynecology instruments, reusable - other
GMDN term
Uterine probe
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.5070
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
Outer Diameter — 32 Millimeter
Length — 32 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201199
8378.00
GUDID
837800
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: Uterine probe

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