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PatCom Distal Chip Endoscope

by Mui Scientific, Division of H&A Mui Enterprises Inc. 2 variants

Ref RP11A2.0

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222587↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00678467508324 UDI-DI Date31 Jul 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0678467RP11AY2 Basic UDI-DI 00678467508324UDI-DIDate7 May 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222587 Date28 Jul 2023IssuedStatusActive

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.

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Mui Scientific
Generic Name
Flexible video nasopharyngoscope
Device Name
PatCom Distal Chip Endoscope
Model / Reference
RP11A2.0
Primary DI / UDI-DI
00678467508324
Basic UDI-DI
0678467RP11AY2
510(k) Number
FDA Product Code
EOB
EMDN Code
Q030199 Nasopharyngeal devices - other
GMDN Term
Flexible video nasopharyngoscope
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.4760
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • 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