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Single-Use Video Hysteroscope
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref RP-G-C0101Model RP-G-C24, RP-G-C0101, RP-G-C0101B
Identity
- Trade Name
- Single-Use Video Hysteroscope EUDAMEDREDPINE FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Single-Use Video Hysteroscope EUDAMED
- Model / Reference
- RP-G-C24, RP-G-C0101, RP-G-C0101B EUDAMEDRP-G-C0101 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972520301018 EUDAMEDFDA UDI
- Basic UDI-DI
- 697252030HYSR01L8 EUDAMED
- 510(k) Number
- K232003 FDA UDI
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 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 Hysteroscope 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 | K241987 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697252030HYSR01L8 | 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 e242ac87-1685-4b16-91a2-af49e1692849 61 fields · synced Jul 20, 2026
- FDA UDI 70700747-6354-4776-87cc-f98436ad6751 33 fields · synced May 30, 2026
- FDA 510(k) K241987 1 fields · synced May 18, 2026