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10fg Double Lumen UPP Catheter with Y-Connector

EUDAMED

Class IIa (EU MDR)

Ref 100100011Model 100100005

by Malvern Medical Developments Ltd also trading as PB Medical Ltd

Identity

Device Name
10fg Double Lumen UPP Catheter with Y-Connector EUDAMED
Model / Reference
100100005 EUDAMED
100100011 EUDAMED

Identifiers

Primary DI / UDI-DI
05060166521608 EUDAMED
Basic UDI-DI
B-05060166521608 EUDAMED
EMDN Code
U05030102 URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

10fg Double Lumen UPP Catheter with Y-Connector by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
GB-MF-000014481
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED a5e38ec2-e720-4566-8a71-c3953edcc93c 61 fields · synced Jul 10, 2026