6fg x 70cm Double Lumen Cystometry Catheter (130cm leads)

EUDAMED

Class IIa (EU MDR)

Ref 100060002 (L) Model 100060002 (L)

by Malvern Medical Developments Ltd also trading as PB Medical Ltd

Identity

Device Name: 6fg x 70cm Double Lumen Cystometry Catheter (130cm leads) EUDAMED
Model / Reference: 100060002 (L) EUDAMED

Identifiers

Primary DI / UDI-DI: 05060166526092 EUDAMED
Basic UDI-DI: B-05060166526092 EUDAMED
EMDN Code: U05010101 CYSTOMANOMETRY CATHETERS, WITHOUT BALLOON, 2-WAY EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

6fg x 70cm Double Lumen Cystometry Catheter (130cm leads) by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05060166526092	Class IIa	Active

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Manufacturer

Manufacturer: Malvern Medical Developments Ltd also trading as PB Medical Ltd
EUDAMED SRN: GB-MF-000014481
Authorised Representative: Advena Limited MT-AR-000000234

Sources (1)

EUDAMED f5f4bc78-87ed-40b0-b661-ccab1d4c0398 61 fields · synced Oct 6, 2026