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Disposable Skin Staplers

by Jinhua Huacheng Medical Appliance Co., Ltd. 11 variants

Ref HC-PFB-55RModel HC-PFB-15R, HC-PFB-15W, HC-PFB-25R, HC-PFB-25W, HC-PFB-35R, HC-PFB-35W, HC-PFB-45R, HC-PFB-45W, HC-PFB-55R, HC-PFB-55W

Active European Union

CE MDR

Valid until

1 Apr 2029

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69233591HC-PFBGE Basic UDI-DI 06923359101072UDI-DIDate14 May 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6141711CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    5 Dec 2024
    Expires
    1 Apr 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable Skin Staplers
Model / Reference
HC-PFB-15R, HC-PFB-15W, HC-PFB-25R, HC-PFB-25W, HC-PFB-35R, HC-PFB-35W, HC-PFB-45R, HC-PFB-45W, HC-PFB-55R, HC-PFB-55W
Primary DI / UDI-DI
06923359101072
Basic UDI-DI
69233591HC-PFBGE
EMDN Code
H02010101 Skin staplers, single-use
Device Class
Class IIa
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000014069
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jinhua Huacheng Medical Appliance Co., Ltd.

See all devices from Jinhua Huacheng Medical Appliance Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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