Shanghai Microport EP Medtech Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 3 device types, 4 products catalogued, 4 clearances.
Shanghai Microport EP Medtech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Trocar, Introducer, Catheter and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
3device types registered with the FDA
4products catalogued under its own name
4510(k) clearances
Registration
| Registered name | SHANGHAI MICROPORT EP MEDTECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009393076 |
| FEI number | 3009393076 |
| DUNS | 542965535 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海微创电生理医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 913101155618553243 |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Building 23&26&28, Lane 588, Tianxiong Rd. |
| Postal code | 201318 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | Class 2 | FORLNK™ Cable for Mapping Catheter, EasyFinder™ Fixed Curve Diagnostic Catheter | 2023 | 5 |
| Introducer, Catheter | Class 2 | PathBuilder Transseptal Guiding Introducer, PathBuilder Steerable Introducer | 2022 | 13 |
| Trocar | Class 2 | PathBuilder Transseptal Needle | 2022 | 9 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| EasyFinder Fixed Curve Diagnostic Catheter | DRF | 56 |
| PathBuilder Transseptal Guiding Introducer | DYB | 40 |
| PathBuilder Transseptal Needle | DRC | 8 |
| PathBuilder Steerable Introducer | DYB | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210313 | 2022-12-30 | DRF | Traditional | This company |
| K212625 | 2022-03-23 | DRC | Traditional | This company |
| K212626 | 2022-03-23 | DYB | Traditional | This company |
| K211530 | 2022-02-08 | DYB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | cardiac ablation catheters, diagnostic catheters, 3D navigation systems, cryoablation solutions |
| Certifications | FDA |
| Export markets | Global |
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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