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QwikCheck Test Strip QC Kit

by M.E.S. Medical Electronic Systems Ltd.

Ref A-CA-01752-00

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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/IVDD EUDAMED NumberB-07290016650440 Basic UDI-DI 07290016650440UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016650440 UDI-DI Date5 Jan 2022ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
QwikCheck Test Strip QC EUDAMED
QwikCheck Test Strip QC Kit GUDID
Generic Name
Sperm energy status and motility testing reagent IVD
Model / Reference
A-CA-01752-00 EUDAMED
QwikCheck Test Strip QC Kit GUDID
Primary DI / UDI-DI
07290016650440
Basic UDI-DI
B-07290016650440
EMDN Code
W05039080 Devices for samples analyses - other accessories
GMDN Term
Sperm energy status and motility testing reagent IVD
Device Class
Class IVD General
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
A-CA-01752-00
GUDID
QwikCheck Test Strip QC Kit

Other devices from M.E.S. Medical Electronic Systems Ltd.

See all devices from M.E.S. Medical Electronic Systems Ltd. →

Properties

  • Single Use
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No