Curatia Medical Limited
Manufacturer and brand owner in Suzhou, Jiangsu, China. 5 device types, 2 products catalogued, 3 clearances.
Curatia Medical Limited is a specification developer holding a current FDA establishment registration. The registration covers Introducer, Catheter, Catheter, Percutaneous and 3 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008261722 |
| FEI number | 3008261722 |
| DUNS | 118745817 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 迪泰医学科技（苏州）有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 198 Xiangjiang Road |
| Postal code | 215011 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | AutoSeal Hemostasis Valve | 2017 | 13 |
| Catheter, Angioplasty, Peripheral, Transluminal | Class 2 | Vela RX PTA Balloon Dilatation Catheter | 2017 | 5 |
| Catheter, Intravascular, Diagnostic | Class 2 | Ursa Angiographic Catheter | 2010 | 11 |
| Catheter, Percutaneous | Class 2 | Navajo PTA Balloon Dilatation Catheter, Xcess Guiding Catheter | 2015 | 14 |
| Introducer, Catheter | Class 2 | EXTesia Introducer Sheath Set | 2022 | 13 |
Own-Brand Listings
Clearances
3 clearances name Curatia Medical Limited as applicant. 3 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220604 | 2022-04-27 | DYB | Traditional | This company |
| K180797 | 2018-12-14 | DQY | Traditional | This company |
| K171290 | 2017-07-19 | LIT | Traditional | This company |
| K141354 | 2015-01-30 | DQY | Traditional | Curative Medical Technology, Inc. |
| K123818 | 2013-03-04 | DQO | Special | Curative Medical Technology, Inc. |
| K090427 | 2010-01-29 | DQO | Traditional | Curative Medical Technology, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Cardiac interventional disposables, Peripheral interventional disposables, Neuro interventional disposables, Pulmonary interventional disposables |
| Certifications | FDA, CE MDR, CFDA, ISO 13485:2016, NMPA YY/T 0287-2017, Korea GMP |
| Export markets | 30+ countries in North America, Europe, South America, Asia |
| OEM and ODM | Offered |
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.
The manufacturer named here can complete this record.