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POCT ampule

by Jiangsu Kehua Medical Instrument Technology Co., Ltd. 17 variants

Model 50μL,60μL,70-2000μL

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697095264POCTA001EP Basic UDI-DI 06970952648091UDI-DIDate23 Sep 2022RegisteredStatusActive

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  • Withdrawn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
POCT ampule
Model / Reference
50μL, 60μL, 70-2000μL
Primary DI / UDI-DI
06970952648091
Basic UDI-DI
697095264POCTA001EP
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028654
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Jiangsu Kehua Medical Instrument Technology Co., Ltd.

See all devices from Jiangsu Kehua Medical Instrument Technology Co., Ltd. →

Properties

Other properties (11)

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