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Pen Injector

by Jiangsu Enjosim Medical Technology Co., Ltd. 4 variants

Ref KXCF-01BModel KXCF-01A

Active European Union

CE MDR

Valid until

1 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

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/MDR Number697663472KXCF-01ABV Basic UDI-DI 06976634720130UDI-DIDate23 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6253932CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    13 Mar 2026
    Expires
    1 Mar 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Pen Injector
Model / Reference
KXCF-01A, KXCF-01B
Primary DI / UDI-DI
06976634720130
Basic UDI-DI
697663472KXCF-01ABV
EMDN Code
A020203 Cartridge syringes
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045016
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Enjosim Medical Technology Co., Ltd.

Properties

  • Reusable
  • Administering Medicine
  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No