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Fluorescence Endoscopes

by Zhuhai Dipu Medical Technology Co., Ltd. China EUDAMEDGUDID

Ref DPM-ENDOSCOPE-0100, DPM-ENDOSCOPE-3D02, /Model DPM-ENDOSCOPE-0100，DPM-ENDOSCOPE-0130, DPM-ENDOSCOPE-3D01,DPM-ENDOSCOPE-3D02

Product code GCJEMDN Z12029009

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697568975fqngjRK Basic UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06975689750482 UDI-DIDate5 Sep 2024ListedStatusIn 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: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Fluorescence Endoscopes EUDAMED
DPM, Endoscopic Fluorescence Camera System GUDID
Generic Name
Rigid optical laparoscope
Model / Reference
DPM-ENDOSCOPE-0100，DPM-ENDOSCOPE-0130 EUDAMED
DPM-ENDOSCOPE-0100 EUDAMED
DPM-ENDOSCOPE-3D01 EUDAMED
DPM-ENDOSCOPE-3D02 EUDAMED
/ EUDAMED
DPM-ENDOSCOPE-0130 GUDID
Primary DI / UDI-DI
06975689750482, 06975689750512, 06975689750529
Basic UDI-DI
697568975fqngjRK, 6975689753DfqngjSP
Direct Marketing DI
06975689750482
06975689750512
06975689750529
510(k) Number
FDA Product Code
GCJ, IZI
EMDN Code
Z12029009 Laparoscopes
GMDN Term
Rigid optical laparoscope
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500, 892.1600
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DPM-ENDOSCOPE-0100，DPM-ENDOSCOPE-0130
DPM-ENDOSCOPE-0100
DPM-ENDOSCOPE-3D01,DPM-ENDOSCOPE-3D02
DPM-ENDOSCOPE-3D02
/
GUDID
DPM-ENDOSCOPE-0130
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000037294
Authorised representative
PureCE B.V. NL-AR-000006069

Other devices from Zhuhai Dipu Medical Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Lot / Batch Number: No

Sources (4)

  • EUDAMED e02ae44d-21c8-4b56-b63d-086db3398d1f 61 fields · synced 22 Oct 2026
  • FDA UDI 65711de4-e56d-467b-bf26-8b0cb7a80f00 33 fields · synced 30 May 2026
  • EUDAMED 06975689750512|6975689753DFQNGJSP 61 fields · synced 9 Jul 2026
  • EUDAMED 06975689750529|6975689753DFQNGJSP 61 fields · synced 9 Jul 2026