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Enema Probes for Radiology, Colonoscopy & defacating proctogram procedures

by Runfold Plastics Ltd 26 variants

Ref MMA-900-0132

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5056622111583UX Basic UDI-DI 05056622100067UDI-DIDate21 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Enema Probes for Radiology, Colonoscopy & defacating proctogram procedures
Model / Reference
MMA-900-0132
Primary DI / UDI-DI
05056622100067
Basic UDI-DI
5056622111583UX
EMDN Code
G02060303 Balloon catheters, barium enema
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
GB-MF-000010291
Authorised representative
International Associates Auditing & Certification Limited IE-AR-000002248

Other devices from Runfold Plastics Ltd

See all devices from Runfold Plastics Ltd →

Properties

Other properties (13)

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