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Single-Use Video Colonoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RP-GI-C02BModel RP-GI-C02A, RP-GI-C02B
Identity
- Trade Name
- REDPINE FDA UDI
- Generic Name
- Flexible video colonoscope, single-use FDA UDI
- Device Name
- Single-Use Video Colonoscope EUDAMED
- Model / Reference
- RP-GI-C02A, RP-GI-C02B EUDAMEDRP-GI-C02B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972520301124 EUDAMEDFDA UDI
- Basic UDI-DI
- 697252030COLF01BC EUDAMED
- 510(k) Number
- K232043 FDA UDI
- FDA Product Code
- FDF FDA UDIFDS FDA UDIFET FDA UDI
- EMDN Code
- Z12020601 COLONOSCOPES EUDAMED
- GMDN Term
- Flexible video colonoscope, 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
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
Yes
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 Colonoscope by Guangzhou Red Pine Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697252030COLF01BC | 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 be52d7a6-f18d-4c29-9b6f-f876ba6ea7fd 61 fields · synced Jul 8, 2026
- FDA UDI 52a265fd-3561-4dae-8287-209a8ce809cf 33 fields · synced May 30, 2026