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XLR8 Abdominal Wound Dressing Kit A4-ABDO1-K

by Genadyne Biotechnologies Inc.

Ref A4-ABDO1-K

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849405024101 Basic UDI-DI 00849405024101UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00849405024101 UDI-DI Date9 Mar 2026ListedStatusListed 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  • Withdrawn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
XLR8 Abdominal Dressing Kit EUDAMED
XLR8 Abdominal Wound Dressing Kit GUDID
Generic Name
Negative-pressure wound therapy open-abdomen dressing
Model / Reference
A4-ABDO1-K
Primary DI / UDI-DI
00849405024101
Basic UDI-DI
B-00849405024101
FDA Product Code
OMP
EMDN Code
M04040601 Polyurethane dressings, non-combined
GMDN Term
Negative-pressure wound therapy open-abdomen dressing
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4780
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Genadyne Biotechnologies Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No