Dongguan ZSR Biomedical Technology Company Limited
Manufacturer and brand owner in Dongguan, Guangdong, China. 2 device types, 1 product catalogued, 2 clearances.
Dongguan ZSR Biomedical Technology Company Limited is a manufacturer holding a current FDA establishment registration. The registration covers Ureteroscope And Accessories, Flexible/Rigid, Endoscopic Access Overtube, Gastroenterology-Urology. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016690337 |
| FEI number | 3016690337 |
| DUNS | 552720970 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 东莞市正生瑞生物医学科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province. |
| Postal code | 523651 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | Disposable Ureteral Guide Sheath | 2025 | 19 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Single-Use Digital Flexible Ureteroscope (F-URS: ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04), Electronic Endoscope Imaging Processor (ZSR-EOS10) | 2025 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Disposable Ureteral Guide Sheath | FED | 10 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243155 | 2025-02-11 | FGB | Traditional | This company |
| K241181 | 2024-08-02 | FED | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | i-MIMERsys Irrigation and Suction Pump, Digital Flexible Ureteroscope, Flexible-Y Type Negative Suction Sheath, Minimally Invasive Surgical Instruments, Endoscopic Imaging Systems |
| Certifications | ISO 13485, MDSAP, NMPA, CE, FDA 510(k) |
| Export markets | China, Asia, Europe, North America, Latin America, Africa |
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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