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8840031

by Richard Wolf GmbH

Ref 8840.031Model 10000201291

8840031 (8840.031) 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 8 Nov 2025 (Basic UDI-DI 405520711032019-0018345AE) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207020890), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number405520711032019-0018345AE Basic UDI-DI 04055207020890UDI-DIDate8 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207020890 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 405520711032019-0018345AE registered 8 Nov 2025 Active
  • FDA GUDID UDI-DI 04055207020890 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207020890
  2. Registered EUDAMED 405520711032019-0018345AE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Rigid optical rectoscope, reusable
Device name
Transanal Endoscopic Microsurgery
Model / Ref / Catalog
10000201291, 8840.031, 8840031
Description
TEM TUBE Ø 40MM WL 137MM WL 137mm, for 8840.21, straight, reusable
Primary DI / UDI-DI
04055207020890
Basic UDI-DI
405520711032019-0018345AE
Direct marketing DI
04055207020890
FDA product code
GCM
EMDN code
L0406 Rigid rectoscopes and anoscopes, reusable
GMDN term
Rigid optical rectoscope, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 40 Millimeter
Length — 137 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201291
8840.031
GUDID
8840031
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: Rigid optical rectoscope, reusable

Similar devices

Also classified as Rigid optical rectoscope, reusable.

Similar devices in this category

Other devices filed under ABDOMINAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)