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Dentsleeve Reusable Catheter

by Mui Scientific, Division of H&A Mui Enterprises Inc. 5 variants

Ref CE4-1316

Expiring European Union

CE MDR

Valid until

18 Jan 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620121250-03 Date9 Mar 2026IssuedStatusExpiring expires 18 Jan 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Dentsleeve Reusable Catheter
Model / Reference
CE4-1316
Primary DI / UDI-DI
00678467507648
Basic UDI-DI
0678467DENTSLEEVEE9
EMDN Code
G010302 Oesophageal manometry, catheters
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CA-MF-000016542
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Mui Scientific, Division of H&A Mui Enterprises Inc.

See all devices from Mui Scientific, Division of H&A Mui Enterprises Inc. →

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