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Fascial Dilator Set

by Biorad Medisys Pvt Ltd 27 variants

Ref BCFD11081622

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number890551609TB Basic UDI-DI 08905516004226UDI-DIDate30 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Fascial Dilator Set
Model / Reference
BCFD11081622
Primary DI / UDI-DI
08905516004226
Basic UDI-DI
890551609TB
EMDN Code
U03010199 Percutaneous nephrostomy, sequential dilators - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000013050
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Biorad Medisys Pvt, Ltd.

See all devices from Biorad Medisys Pvt, 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