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Hybrid Dressing UP-D1520

by Genadyne Biotechnologies Inc.

Ref UP-D1520

Hybrid Dressing UP-D1520 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 9 Jun 2026 (Basic UDI-DI B-00849405001652) and listed in FDA GUDID since 31 Jul 2024 (UDI-DI 00849405001652), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849405001652 Basic UDI-DI 00849405001652UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00849405001652 UDI-DI Date31 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00849405001652 registered 9 Jun 2026 Active
  • FDA GUDID UDI-DI 00849405001652 listed 31 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00849405001652
  2. Registered EUDAMED B-00849405001652

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  • Withdrawn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
Hybrid Dressing 15 x 20 cm EUDAMED
Hybrid Dressing GUDID
Generic name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device name
UNO Hybrid Dressing 15 x 20 cm
Model / reference
UP-D1520
Primary DI / UDI-DI
00849405001652
Basic UDI-DI
B-00849405001652
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
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

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