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Clozex Wound Closure CL1040S

by Clozex Medical, Inc.

Ref CL1040SModel CL1015S

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850019787ProMedXW Basic UDI-DI 00850019787085UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850019787085 UDI-DI Date28 Oct 2025ListedStatusListed 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  • Withdrawn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
Clozex Closure EUDAMED
Clozex Wound Closure GUDID
Generic Name
Skin-closure adhesive strip
Model / Reference
CL1040S, CL1015S
Primary DI / UDI-DI
00850019787085
Basic UDI-DI
0850019787ProMedXW
FDA Product Code
MZR
EMDN Code
H900102 Bandages for sutures
GMDN Term
Skin-closure adhesive strip
Device Class
Class I
Regulation Number
880.5240
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from Clozex Medical, Inc.

See all devices from Clozex Medical, Inc. →

Properties

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

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No