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Mui Scientific CE4-1340

by H & A Mui Enterprises Inc

Ref CE4-1340

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

18 Jan 2027

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00678467508461 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number28620121250-03 Date9 Mar 2026IssuedStatusExpiring expires 18 Jan 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mui Scientific
Generic Name
Gastrointestinal motility manometric catheter, non-electronic
Device Name
Dentsleeve Reusable Catheter
Model / Reference
CE4-1340
Primary DI / UDI-DI
00678467508461
Basic UDI-DI
0678467DENTSLEEVEE9
510(k) Number
FDA Product Code
FFX
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
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K983665)

Other devices from H & A Mui Enterprises Inc

See all devices from H & A Mui Enterprises Inc →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No