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SequaFilm

by Foshan United Medical Technologies Ltd.

Ref SQ130607OUModel many

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

CE MDR

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/MDR EUDAMED Number693113223419B3 Basic UDI-DI 06931132220063UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06931132220063 UDI-DI Date9 May 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SequaFilm EUDAMED
SequaFilm PU Film Dressing GUDID
Generic Name
Synthetic polymer semi-permeable film dressing, adhesive
Device Name
Polyurethane film dressings
Model / Reference
many, SQ130607OU
Primary DI / UDI-DI
06931132220063
Basic UDI-DI
693113223419B3
Direct Marketing DI
06931132220063
FDA Product Code
NAD
EMDN Code
M04040601 Polyurethane dressings, non-combined
GMDN Term
Synthetic polymer semi-permeable film dressing, adhesive
Device Class
Class I
Regulation Number
878.4020
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000017922
Authorised representative
Medwheat Tech Service GmbH DE-AR-000006844

Related devices

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Other devices from Foshan United Medical Technologies Ltd.

See all devices from Foshan United Medical Technologies Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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