Single-Use Video Flexible Ureterorenoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Single-Use Video Flexible Ureterorenoscope EUDAMEDREDPINE FDA UDI
- Generic Name
- Flexible video ureterorenoscope, single-use FDA UDI
- Device Name
- Single-Use Video Flexible Ureterorenoscope EUDAMED
- Model / Reference
- RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305B EUDAMEDRP-U-C0305R3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972520301803 EUDAMED06972520300899 FDA UDI
- Basic UDI-DI
- 697252030UREF01J6 EUDAMED
- 510(k) Number
- K221158 FDA UDI
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureterorenoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Flexible video ureteroscope, single-use
Single-Use Video Flexible Ureterorenoscope by Guangzhou Red Pine Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697252030UREF01J6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012833
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 2620ebdd-cdcf-4418-a96c-d0d6e7097463 61 fields · synced May 31, 2026
- FDA UDI 56c9143a-cec0-4d0d-9224-2230fce13ca2 33 fields · synced May 29, 2026