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XLR8 DUO Instill Foam Dressing Kit Small

by Genadyne Biotechnologies, Inc.

Ref DIF-SPSMF1

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00849405002161 Basic UDI-DI 00849405002161UDI-DIDate18 Jun 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
DUO Instill Foam Dressing Kit Small
Model / Reference
DIF-SPSMF1
Primary DI / UDI-DI
00849405002161
Basic UDI-DI
B-00849405002161
EMDN Code
M04040601 Polyurethane dressings, non-combined
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
US-MF-000017992
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Sterile

Other properties (10)

  • 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