Ezisurg Medical Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 2 device types, 5 products catalogued, 5 clearances.
Ezisurg Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Stapler, Surgical, Staple, Implantable. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
2device types registered with the FDA
5products catalogued under its own name
5510(k) clearances
Registration
| Registered name | EZISURG MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014264910 |
| FEI number | 3014264910 |
| DUNS | 421348845 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海逸思医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91310115586781472J |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 399, Miaoqiao Rd., Pudong New District, |
| Postal code | 201315 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Staple, Implantable | Class 2 | easyEndo Linear Cutting Stapler for Single Use (F12S, F12M, F12L), easyEndo Universal Linear Cutting Stapler (U12S, U12M, U12L), easyEndo Flex Loading Unit (R30W, R30B, R45W, R45B, R45C, R45G, R60W, R60B, R60C, R60G), easyEndo Pro Loading Unit (L30W, L30B, L45W, L45B, L45C, L45G, L60W, L60B, L60C, L60G), easyEndo Loading Units for Single Use (FDU45W, FDU45B, FDU45G, FDU60B, FDU60G), easyCS Circular Stapler for Single Use (CS2135, CS2148, CS2535, CS2548, CS2935, CS2948, CS3148, CS3348) and 6 more | 2018 | 16 |
| Stapler, Surgical | Class 2 | easyEndo Lite Loading Units for Single Use (N45M, N45W, N45B, N45C, N45G, N60M, N60W, N60B, N60C, N60G), easyEndo Lite Linear Cutting Stapler for Single Use (U12S45, U12S60, U12M45, U12M60, U12L45, U12L60) | 2021 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | GDW | 23 |
| easyLCTM Linear Cutter Staplers and Loading Units for Single Use | GDW | 17 |
| easyEndoTM Lite Loading Unit for Single Use | GDW | 10 |
| easyCSTM Circular Stapler for Single Use | GDW | 8 |
| easyEndoTM Lite Linear Cutting Stapler for Single Use | GAG | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210909 | 2021-06-24 | GDW | Traditional | This company |
| K183477 | 2019-02-11 | GDW | Traditional | This company |
| K181657 | 2019-02-01 | GDW | Traditional | This company |
| K172960 | 2017-12-21 | GDW | Traditional | This company |
| K143129 | 2015-01-29 | GDW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Surgical Stapling Series, Energy Sealing Platform, Endoscopy Platform, Powered Endoscopic Staplers |
| Certifications | FDA clearance, CE MDR certification |
| Export markets | Over 70 countries |
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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