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4.5fg x 200cm Rectal Catheter with PVC Balloon

by Malvern Medical Developments Ltd also trading as PB Medical Ltd

Ref 212045Model 200045001

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060166520274 Basic UDI-DI 05060166520274UDI-DIDate16 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
4.5fg x 200cm Rectal Catheter with PVC Balloon
Model / Reference
200045001, 212045
Primary DI / UDI-DI
05060166520274
Basic UDI-DI
B-05060166520274
EMDN Code
U050402 Intra-abdominal pressure measurement catheters, with balloon
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

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

Other devices from Malvern Medical Developments Ltd also trading as PB Medical Ltd

See all devices from Malvern Medical Developments Ltd also trading as PB Medical Ltd →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No