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pNOVUS 21 Microcatheter

by phenox Ltd Ireland EUDAMEDGUDID

Ref PNOV-21-150Model PNOV-21-160 Product code DQOEMDN C0104020202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05391530910408 UDI-DIDate2 Dec 2024ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number2245542TD01 Date5 Jul 2024IssuedStatusActive expires 1 Feb 2029

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2245542CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    14 Feb 2024
    Expires
    1 Feb 2029
  • 2245542TD01 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    5 Jul 2024
    Expires
    1 Feb 2029

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
pNOVUS 21 Microcatheter EUDAMED
pNOVUS 21 Microcatheter (150cm) GUDID
Generic Name
Vascular microcatheter
Model / Reference
PNOV-21-160, PNOV-21-150
Primary DI / UDI-DI
05391530910408 EUDAMED
05391530910378 GUDID
Basic UDI-DI
539153091pNOVUSFAMILYYK
510(k) Number
FDA Product Code
DQO, QJP
EMDN Code
C0104020202 Peripheral embolisation catheters and microcatheters
GMDN Term
Vascular microcatheter
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1200, 870.1250
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Size
Catheter Length — 150 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05391530910408
GUDID
05391530910378
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
IE-MF-000011333

Other devices from Phenox Limited

See all devices from Phenox Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 53292b12-488f-4f9b-8908-fecf3e6a95e1 61 fields · synced 24 Oct 2026
  • FDA UDI 1b811a56-ecf2-40d9-839e-59fb40ab1589 35 fields · synced 30 May 2026