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Foam Kit Medium XF-DMDF1

by Genadyne Biotechnologies Inc.

Ref XF-DMDF1

Foam Kit Medium XF-DMDF1 is a medical device (EU MDD Class IIb; FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump; EMDN category polyurethane dressings) made by Genadyne Biotechnologies Inc., registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI B-00849405021124), cleared under FDA 510(k) K092992 on 29 Jun 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00849405021124), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092992

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849405021124 Basic UDI-DI 00849405021124UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00849405021124 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK092992 Date29 Jun 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00849405021124 registered 12 Jun 2026 Active
  • FDA 510(k) K092992 decided 29 Jun 2010 Active
  • FDA GUDID UDI-DI 00849405021124 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092992
  2. Listed FDA GUDID 00849405021124
  3. Registered EUDAMED B-00849405021124

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Foam Kit Medium
Generic name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device name
XLR8 Foam Kit Medium
Model / reference
XF-DMDF1
Primary DI / UDI-DI
00849405021124
Basic UDI-DI
B-00849405021124
510(k) Number
FDA product code
OMP
EMDN code
M04040601 Polyurethane dressings, non-combined
GMDN term
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4780
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00849405021124: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb 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: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Cleared under the same submission (K092992)

and 8 more cleared under K092992

Similar devices in this category

Other devices filed under POLYURETHANE DRESSINGS, NON-COMBINED.

Other devices from Genadyne Biotechnologies Inc.

See all devices from Genadyne Biotechnologies Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)