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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

pNOVUS 21 Microcatheter — Class III MDR by phenox Ltd

MD Atlas
phenox Ltd

EUDAMED last updated this device on May 9, 2025

pNOVUS 21 Microcatheter

539153091pNOVUSFAMILYYK

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: phenox Ltd
UDI-DI code: 05391530910149
Reference / catalog number: PNOV-21-160

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Manufacturer information

Organization name: phenox Ltd
SRN: IE-MF-000011333
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW999
Removing the introducer sheath from the microcatheter without a guidewire inserted may cause damage to the microcatheter.
CW999
Excessive tightening of the RHV around the microcatheter may lead to damage of the device.
CW010
Refer to Warnings, Precautions, and Potential Adverse Event’s prior to use.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Feb 14, 2024	Feb 1, 2029

Device identification

Trade name: pNOVUS 21 Microcatheter
UDI-DI code: 05391530910149
Basic UDI-DI: 539153091pNOVUSFAMILYYK
Reference / catalog number: PNOV-21-160
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 160cm

EMDN nomenclature code(s)

C0104020202PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Related devices

pNOVUS 21 Microcatheter539153091pNOVUSFAMILYYKOn the market pNOVUS 21 Microcatheter539153091pNOVUSFAMILYYKOn the market