Skip to content

8 Spirally Aligned Channels with Balloon, 3.9mm

by Malvern Medical Developments Ltd also trading as PB Medical Ltd 2 variants

Ref 500039048Model AHB5291

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060166520878 Basic UDI-DI 05060166520878UDI-DIDate12 Dec 2024RegisteredStatusActive

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  • Withdrawn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
8 Spirally Aligned Channels with Balloon, 3.9mm
Model / Reference
AHB5291, 500039048
Primary DI / UDI-DI
05060166520878
Basic UDI-DI
B-05060166520878
EMDN Code
G02060305 Colorectal manometry catheters
Device Class
Class IIa
EU market of registration
Netherlands

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