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Carilex

by Carilex Medical, Inc 24 variants

Ref S1001-2140

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

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 Number471361609S1XXXCJ Basic UDI-DI 04713616091381UDI-DIDate14 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04713616091381 UDI-DI Date12 Jun 2018ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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

Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Name
Negative Pressure Wound Therapy System (Dressing Kit)
Model / Reference
S1001-2140
Primary DI / UDI-DI
04713616091381
Basic UDI-DI
471361609S1XXXCJ
510(k) Number
FDA Product Code
OMP
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000002145
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Carilex Medical, Inc.

See all devices from Carilex Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No