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Sample Collection Kit

by Jiangsu CoWin Biotech Co., Ltd. 12 variants

Ref CWX033H-NModel CWX033H-O/CWX033H-N/CWX033H-ON/CWX033H-O-P/CWX033H-N-P/CWX033H-ON-P/ CWX034H-O/CWX034H-N/CWX034H-ON/CWX034H-O-P/CWX034H-N-P/CWX034H-ON-P

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697445472V22003X033X0348C Basic UDI-DI 06974454727599UDI-DIDate27 Oct 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Sample Collection Kit
Model / Reference
CWX033H-O/CWX033H-N/CWX033H-ON/CWX033H-O-P/CWX033H-N-P/CWX033H-ON-P/ CWX034H-O/CWX034H-N/CWX034H-ON/CWX034H-O-P/CWX034H-N-P/CWX034H-ON-P, CWX033H-N
Primary DI / UDI-DI
06974454727599
Basic UDI-DI
697445472V22003X033X0348C
Direct Marketing DI
06974454727599
EMDN Code
A1102 Sample collection swabs with transport medium
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008981
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: General-purpose absorbent tip applicator/swab, single-use

Other devices from Jiangsu CoWin Biotech Co., Ltd.

See all devices from Jiangsu CoWin Biotech Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No