FDA Registration
Active
🇨🇳 China
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.
Reg #: 3021246306
·
FEI: 3021246306
·
Expires 2026
Products
8
Proprietary Names
12
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.
- Registration Number
- 3021246306
- FEI Number
- 3021246306
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 501, 502, 503 and 701-02 Building 22, No.388 Lianyun Road, Huangpu District, 510000 Guangzhou City, Guang
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232043
Owner / Operator
- Firm Name
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Operator Number
- 10083216
- Address
- 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510000
- Country
- CN
- Correspondent
- Weihua Yang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2024-08-18 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2024-08-18 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2024-08-18 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2023-04-18 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-08-18 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-08-04 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2025-04-02 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2021-11-03 |
Proprietary Names
Endoscopic Video Image Processor
Single-Use Video Gastroscope
Single-Use Video Colonoscope
Ascend Single-Use Flexible Ureteroscope
Single-Use Video Flexible Ureterorenoscope
Single-Use Video Flexible Cystoscope
Single-Use Video Hysteroscope
Single-Use Video Flexible Cysto-Nephroscope
Ascend Single-Use Flexible Cysto-Nephroscope HD
Endoscopic Video Image Processor HD
Single-Use Endoscopic Scissors
Single-Use Biopsy Forceps
Establishment Types
Manufacture Medical Device