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Debrisoft Pad 10x10cm

by Lohmann & Rauscher International GmbH & Co KG

Ref 34321Model Wound Debridement Pad, non-invasive

Debrisoft Pad 10x10cm (34321) is a manual wound debridement tool (EU MDR Class IIb; FDA Class I; FDA product code NAB, Gauze / Sponge,Nonresorbable For External Use) made by Lohmann & Rauscher International GmbH & Co KG, registered in EUDAMED on 18 Jun 2026 (Basic UDI-DI 4021447-0091-L2) and listed in FDA GUDID since 17 Nov 2022 (UDI-DI 04056649070344), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4021447-0091-L2 Basic UDI-DI 04056649070344UDI-DIDate18 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056649070344 UDI-DI Date17 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4021447-0091-L2 registered 18 Jun 2026 Active
  • FDA GUDID UDI-DI 04056649070344 listed 17 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04056649070344
  2. Registered EUDAMED 4021447-0091-L2

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  • Withdrawn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

Trade name
Debrisoft
Generic name
Manual wound debridement tool
Model / Ref / Catalog
Wound Debridement Pad, non-invasive, 34321, Pad 10x10cm
Primary DI / UDI-DI
04056649070344
Basic UDI-DI
4021447-0091-L2
FDA product code
NAB
EMDN code
M040703 Wound debridement pads
GMDN term
Manual wound debridement tool
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
878.4014
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Wound Debridement Pad, non-invasive
34321
GUDID
Pad 10x10cm
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Wound debridement tool

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Other devices filed under SPECIAL PADS.

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Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)