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Single-Use Video Hysteroscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RP-G-C24Model 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-C24 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972520301001 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
Category: Rigid video hysteroscope
Single-Use Video Hysteroscope by Guangzhou Red Pine Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HTx Jednorazowy Histeroskop — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
- Histeroscópio Descartável HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
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 | 697252030HYSR01L8 | 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 6712e5fd-4def-4a3f-8244-4065de7c9fbd 61 fields · synced Jun 8, 2026
- FDA UDI 8bf20869-486e-4f29-b1e7-cb97fe27ddcf 33 fields · synced May 29, 2026