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Capnography CO2 sample line

by Qinhuangdao Kapunuomaite Medical Equipment S&T Co., Ltd. 9 variants

Ref 5212S-30Model 5212S-10、5212S-50、5212S-20、5212S-30、5212S-31、5212S-32、5213N-10、5213N-20、5210S-10、5210S-20、5210S-30

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697298445521QH Basic UDI-DI 06972984450215UDI-DIDate23 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Capnography CO2 sample line
Model / Reference
5212S-10、5212S-50、5212S-20、5212S-30、5212S-31、5212S-32、5213N-10、5213N-20、5210S-10、5210S-20、5210S-30, 5212S-30
Primary DI / UDI-DI
06972984450215
Basic UDI-DI
697298445521QH
EMDN Code
Z1203020485 Gaseous exchange monitoring instruments - consumables
Device Class
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000018626
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

From the manufacturer

Manufacturer's product page: EtCO2 Sensors

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Properties

Other properties (13)

  • Sterile: 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