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Eragon Modular 8395234

by Richard Wolf GmbH

Ref 8395.234Model 10000277444

Eragon Modular 8395234 (8395.234) is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04055207016794) and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 04055207016794), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207016794 Basic UDI-DI 04055207016794UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207016794 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207016794 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207016794 listed 28 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207016794
  2. Registered EUDAMED B-04055207016794

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  • Withdrawn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

Trade name
Eragon Modular
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Device name
Modular grasping forceps inserts, non HF
Model / Ref / Catalog
10000277444, 8395.234, 8395234
Description
PLATE SHAPED GRASP.FORCEPS INS. Ø 10MM jaw length 50mm, for SL 327mm, double action, reusable
Primary DI / UDI-DI
04055207016794
Basic UDI-DI
B-04055207016794
FDA product code
GEN
EMDN code
L1204 Laparoscopic and thoracoscopic surgery forceps, reusable
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class I
Regulation number
878.4800
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 — 10 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000277444
8395.234
GUDID
8395234

Related devices

Category: Rigid endoscopic tissue manipulation forceps, reusable

Similar devices in this category

Other devices filed under LAPAROSCOPIC AND THORACOSCOPIC SURGERY FORCEPS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)