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Na S1002-0022

by Carilex Medical, Inc.

Ref S1002-0022

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719873691296 UDI-DI Date22 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number471987369S1XXXRV Basic UDI-DI 04719873691296UDI-DIDate6 Feb 2023RegisteredStatusActive

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 23 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  • Withdrawn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

Trade Name
Carilex
Generic Name
Negative-pressure wound therapy system pump, electric
Device Name
Negative Pressure Wound Therapy System
Model / Reference
S1002-0022
Primary DI / UDI-DI
04719873691296
Basic UDI-DI
471987369S1XXXRV
Direct Marketing DI
04719873691296
510(k) Number
FDA Product Code
OMP
EMDN Code
Z12019003 Wound treatment equipment
GMDN Term
Negative-pressure wound therapy system pump, electric
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4780
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Negative-pressure wound therapy system pump, electric

Cleared under the same submission (K231646)

Other devices from Carilex Medical, Inc.

See all devices from Carilex Medical, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No