Skip to content

UNO 20x25 Dressing Kit UNO-0810

by Genadyne Biotechnologies Inc.

Ref UNO-0810

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849405021582 Basic UDI-DI 00849405021582UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00849405021582 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
UNO 20x25 Dressing EUDAMED
UNO 20x25 Dressing Kit GUDID
Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Model / Reference
UNO-0810
Primary DI / UDI-DI
00849405021582
Basic UDI-DI
B-00849405021582
FDA Product Code
OMP
EMDN Code
M04040701 Silicone 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 market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Genadyne Biotechnologies Inc.

See all devices from Genadyne Biotechnologies Inc. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No