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
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697568975fqngjRK | Date13 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06975689750482 | Date5 Sep 2024 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Fluorescence Endoscopes EUDAMEDDPM, Endoscopic Fluorescence Camera System GUDID
- Generic Name
- Rigid optical laparoscope
- Model / Reference
- DPM-ENDOSCOPE-0100,DPM-ENDOSCOPE-0130 EUDAMEDDPM-ENDOSCOPE-0100 EUDAMEDDPM-ENDOSCOPE-3D01 EUDAMEDDPM-ENDOSCOPE-3D02 EUDAMED/ EUDAMEDDPM-ENDOSCOPE-0130 GUDID
- Primary DI / UDI-DI
- 06975689750482, 06975689750512, 06975689750529
- Basic UDI-DI
- 697568975fqngjRK, 6975689753DfqngjSP
- Direct Marketing DI
- 069756897504820697568975051206975689750529
- 510(k) Number
- FDA Product Code
- GCJ, IZI
- EMDN Code
- Z12029009 Laparoscopes
- GMDN Term
- Rigid optical laparoscope
- Device Class
- Class IIa EUDAMEDClass 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
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | DPM-ENDOSCOPE-0100,DPM-ENDOSCOPE-0130 DPM-ENDOSCOPE-0100 DPM-ENDOSCOPE-3D01,DPM-ENDOSCOPE-3D02 DPM-ENDOSCOPE-3D02 / | DPM-ENDOSCOPE-0130 |
| Device Class | Class IIa | 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
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
- FDA UDI 65711de4-e56d-467b-bf26-8b0cb7a80f00
- EUDAMED 06975689750512|6975689753DFQNGJSP
- EUDAMED 06975689750529|6975689753DFQNGJSP