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Single-Use Video Flexible Cystoscope
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref RP-U-C0201Model RP-U-C0201, RP-U-C0201S
Identity
- Trade Name
- Single-Use Video Flexible Cystoscope EUDAMEDREDPINE FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- Single-Use Video Flexible Cystoscope EUDAMED
- Model / Reference
- RP-U-C0201, RP-U-C0201S EUDAMEDRP-U-C0201 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972520300783 EUDAMEDFDA UDI
- Basic UDI-DI
- 697252030CYSF01GB EUDAMED
- 510(k) Number
- K240663 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Single-Use Video Flexible Cystoscope by Guangzhou Red Pine Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240663 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697252030CYSF01GB | Class IIa | Active |
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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 (3)
- EUDAMED 364ec911-e8db-4b7a-bba1-8c1bdf4dd0d4 61 fields · synced Jul 30, 2026
- FDA UDI e532a50c-7607-4206-82cd-3d6740e0b874 33 fields · synced May 29, 2026
- FDA 510(k) K240663 1 fields · synced May 18, 2026