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PINECY® Inflation Device for Balloon Catheters

by Princeton Medical Scientific Co., Ltd 2 variants

Ref FA10001

Active European Union

CE MDR

Valid until

16 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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 NumberCN26/00000404 Date16 Jan 2026IssuedStatusActive expires 16 Jan 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00000404 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    16 Jan 2026
    Expires
    16 Jan 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FA10001
Primary DI / UDI-DI
06935456211943
Basic UDI-DI
69354562PLYL10XC
Direct Marketing DI
06935456211943
EMDN Code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000018402
Authorised representative
Wellkang Ltd XI-AR-000001836

Related devices

Category: General internal orthopaedic fixation system implantation kit

Other devices from Princeton Medical Scientific Co., Ltd

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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