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Zeeland

by Cnovate Medical B.V. 167 variants

Ref PS14-040020-090, PS14-025150-070, Zeeland, PS14-055030-150, PS14-035005-070, PS14-045200-150, PS14-050150-150, PS14-030200-150, PS14-020100-090, PS14-040060-070, PS14-025010-070, PS14-045015-070, PS14-045020-070, PS14-030040-150, PS14-035100-150, PS14-035020-070, PS14-055015-070, PS14-045005-070, PS14-060020-070, PS14-050150-070, PS14-040200-150, PS14-050080-150, PS14-025020-090, PS14-040015-090, PS14-040100-150, PS14-025005-150, PS14-015100-090, PS14-060010-090, PS14-020010-150, PS14-015020-070, PS14-060080-070, PS14-035120-150, PS14-020030-070, PS14-060060-150, PS14-015150-070, PS14-015100-070, PS14-015010-150, PS14-035015-090, PS14-030020-150, PS14-060015-150, PS14-015200-070, PS14-035060-150, PS14-045080-070, PS14-045020-150, PS14-015010-090, PS14-020080-150, PS14-045200-090, PS14-030150-070, PS14-030040-090, PS14-050120-070, PS14-030030-090

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number872062130003AF Basic UDI-DI Date29 Apr 2025RegisteredStatusActive

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  • Withdrawn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
Zeeland PTA Balloon Dilatation Catheter
Model / Reference
PS14-040020-090, PS14-025150-070, Zeeland, PS14-055030-150, PS14-035005-070, PS14-045200-150, PS14-050150-150, PS14-030200-150, PS14-020100-090, PS14-040060-070, PS14-025010-070, PS14-045015-070, PS14-045020-070, PS14-030040-150, PS14-035100-150, PS14-035020-070, PS14-055015-070, PS14-045005-070, PS14-060020-070, PS14-050150-070, PS14-040200-150, PS14-050080-150, PS14-025020-090, PS14-040015-090, PS14-040100-150, PS14-025005-150, PS14-015100-090, PS14-060010-090, PS14-020010-150, PS14-015020-070, PS14-060080-070, PS14-035120-150, PS14-020030-070, PS14-060060-150, PS14-015150-070, PS14-015100-070, PS14-015010-150, PS14-035015-090, PS14-030020-150, PS14-060015-150, PS14-015200-070, PS14-035060-150, PS14-045080-070, PS14-045020-150, PS14-015010-090, PS14-020080-150, PS14-045200-090, PS14-030150-070, PS14-030040-090, PS14-050120-070, PS14-030030-090
Primary DI / UDI-DI
08720621344049, 08720621340355, 08720621343554, 08720621345411, 08720621340492, 08720621345244, 08720621345350, 08720621342489, 08720621341215, 08720621343073, 08720621340263, 08720621343158, 08720621343165, 08720621342427, 08720621342571, 08720621340522, 08720621343394, 08720621343134, 08720621343523, 08720621343356, 08720621345121, 08720621345329, 08720621341284, 08720621344032, 08720621345091, 08720621342250, 08720621341093, 08720621344506, 08720621342144, 08720621340041, 08720621343561, 08720621342588, 08720621340171, 08720621345558, 08720621340119, 08720621340096, 08720621342021, 08720621341512, 08720621342403, 08720621345510, 08720621340126, 08720621342557, 08720621343202, 08720621345169, 08720621341024, 08720621342205, 08720621344247, 08720621340478, 08720621341420, 08720621343349, 08720621341413
Basic UDI-DI
872062130003AF
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000006042

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from Cnovate Medical B.V.

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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