pNOVUS 21 Microcatheter

by phenox Ltd EUDAMED

Active European Union

Ref PNOV-21-160

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number2245542TD01	Date5 Jul 2024Issued	StatusActive expires 1 Feb 2029
European Union	CE/MDR	Number539153091pNOVUSFAMILYYK Basic UDI-DI	Date27 Feb 2024Registered	StatusActive
European Union	CE/MDR	Number2245542CE01	Date14 Feb 2024Issued	StatusActive expires 1 Feb 2029

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

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

Model / Reference: PNOV-21-160

Primary DI / UDI-DI: 05391530910149
Basic UDI-DI: 539153091pNOVUSFAMILYYK
EMDN Code: C0104020202 Peripheral embolisation catheters and microcatheters

Device Class: Class III
Market of Registration: Ireland

Manufacturer details

EUDAMED SRN: IE-MF-000011333

Other devices from Phenox Limited

Esperance pHLO Aspiration System PHLO-AC-71-125

Class II
Esperance pHLO Aspiration System PHLO-AC-71-135

Class II
pRESET® Delta LITE Thrombectomy Device (3mm x 20mm) PRE2-LT-3-20

Class II
pRESET® Delta LITE Thrombectomy Device (4mm x 20mm) PRE2-LT-4-20

Class II
pORTAL® Steerable Hydrophilic Guidewire PORT-14-200-1

Class II
pRESET® LITE Thrombectomy Device (3mm x 20mm) PRE-LT-3-20

Class II

See all devices from Phenox Limited →

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