Guangzhou RED Pine Medical Instrument Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 8 device types, 11 products catalogued, 9 clearances.
Guangzhou RED Pine Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Hysteroscope Accessories, Forceps, Biopsy, Non-Electric and 6 other device types. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
8device types registered with the FDA
11products catalogued under its own name
9510(k) clearances
Registration
| Registered name | GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021246306 |
| FEI number | 3021246306 |
| DUNS | 417649868 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广州瑞派医疗器械有限责任公司 |
|---|---|
| Unified social credit code | 91440116MA59B2J00D |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Room 501, 502, 503 and 701-02 Building 22, No.388 Lianyun Road, Huangpu District, 510000 Guangzhou City, Guang |
| Postal code | 510000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | Class 2 | Single-Use Video Gastroscope, Endoscopic Video Image Processor, Single-Use Video Colonoscope | 2024 | 9 |
| Cystoscope And Accessories, Flexible/Rigid | Class 2 | Ascend™ Single-Use Flexible Cysto-Nephroscope HD, Single-Use Video Flexible Cysto-Nephroscope, Endoscopic Video Image Processor, Single-Use Video Flexible Cystoscope | 2024 | 16 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class 2 | Single-Use Video Gastroscope, Endoscopic Video Image Processor, Single-Use Video Colonoscope | 2024 | 8 |
| Forceps, Biopsy, Non-Electric | Class 1 | Single-Use Biopsy Forceps | 2021 | 44 |
| Gastroscope And Accessories, Flexible/Rigid | Class 2 | Single-Use Video Gastroscope, Endoscopic Video Image Processor, Single-Use Video Colonoscope | 2024 | 9 |
| Hysteroscope (And Accessories) | Class 2 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | 2024 | 13 |
| Hysteroscope Accessories | Class 1 | Single-Use Endoscopic Scissors | 2025 | 11 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Endoscopic Video Image Processor, Ascend™ Single-Use Flexible Ureteroscope, Single-Use Video Flexible Ureterorenoscope, Endoscopic Video Image Processor HD | 2023 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Redpine | FGB | 16 |
| Ascend™ Single-Use Flexible Ureteroscope | FGB | 12 |
| Redpine | FDF | 8 |
| Redpine | FAJ | 5 |
| Redpine | FCL | 4 |
| Single-Use Video Flexible Ureterorenoscope | FGB | 4 |
| Redpine | HIH | 2 |
| Ascend™ Single-Use Flexible Cysto-Nephroscope HD | FAJ | 2 |
| Endoscopic Video Image Processor HD | FGB | 1 |
| Endoscopic Video Image Processor | FET | 1 |
| Single-Use Endoscopic Scissors | NWW | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251951 | 2025-12-16 | FGB | Traditional | This company |
| K252176 | 2025-08-08 | FAJ | Special | This company |
| K243321 | 2025-02-07 | FET | Traditional | This company |
| K241987 | 2024-08-02 | HIH | Special | This company |
| K241500 | 2024-07-12 | FAJ | Traditional | This company |
| K240663 | 2024-06-21 | FAJ | Traditional | This company |
| K232043 | 2024-02-16 | FDF | Traditional | This company |
| K232003 | 2024-02-12 | HIH | Traditional | This company |
| K221158 | 2023-03-06 | FGB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | single-use endoscopes, endoscope image processors, single-use intraoperative instruments |
| Certifications | CE, CE-MDR, FDA 510(k) |
| Export markets | Europe, USA, Middle East, Australia, Asia-Pacific |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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