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Dentsleeve Reusable Catheter

by Mui Scientific, Division of H&A Mui Enterprises Inc. Canada EUDAMEDGUDID

Ref CE4-1302

Product code KLAEMDN G010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620121250-03 Date9 Mar 2026IssuedStatusExpiring expires 18 Jan 2027
United StatesGUDID listing GUDID Number00678467507310 UDI-DIDate17 Mar 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620121250-03 Issued Expires in 86 days

    Quality management system EU MDR

    Notified body
    Intertek Medical Notified Body AB 2862
    Issued
    9 Mar 2026
    Expires
    18 Jan 2027

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Mui Scientific
Generic Name
Gastrointestinal motility manometric catheter, non-electronic
Device Name
Dentsleeve Reusable Catheter
Model / Reference
CE4-1302
Primary DI / UDI-DI
00678467507310
Basic UDI-DI
0678467DENTSLEEVEE9
510(k) Number
FDA Product Code
KLA
EMDN Code
G010302 Oesophageal manometry, catheters
GMDN Term
Gastrointestinal motility manometric catheter, non-electronic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1725
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Serial Number
Other properties (22)
  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED ff535f04-e3ec-4245-a1dc-59f81301e5cd 61 fields · synced 22 Oct 2026
  • FDA UDI 4d472277-b6c8-4ed2-8051-4c12ade4b5b7 35 fields · synced 30 May 2026