Kossel Medtech (Suzhou) Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 4 device types, 7 products catalogued, 5 clearances.
Kossel Medtech (Suzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers General Use Pneumatic Tourniquet, Syringe, Balloon Inflation, Exempt and 2 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | KOSSEL MEDTECH (SUZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014390222 |
| FEI number | 3014390222 |
| DUNS | 560219894 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 科塞尔医疗科技（苏州）有限公司 |
|---|---|
| Unified social credit code | 91320505084409873L |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 6, No.8 Jinfeng Road, Suzhou New District, Jiangsu, 215163, China |
| Postal code | 215163 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | Class 2 | Falexpand HP PTA Balloon Dilatation Catheter, Falspeed PTA Balloon Dilatation Catheter | 2023 | 5 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class 2 | Selethru PTCA Balloon Dilatation Catheter, Selebrek PTCA Balloon Dilatation Catheter, Selethru NC PTCA Balloon Dilatation Catheter | 2019 | 12 |
| General Use Pneumatic Tourniquet | Class 1 | Selestem Radial Artery Tourniquet | 2020 | 5 |
| Syringe, Balloon Inflation, Exempt | Class 2 | Selepump Inflation Device | 2020 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Falexpand HP PTA Balloon Dilatation Catheter | LIT | 203 |
| Falspeed PTA Balloon Dilatation Catheter | LIT | 176 |
| Selethru NC Ptca Balloon Dilatation Catheter | LOX | 83 |
| Selethru Ptca Balloon Dilatation Catheter | LOX | 44 |
| Selebrek Ptca Balloon Dilatation Catheter | LOX | 9 |
| Selethru Ptca Dilatation Balloon Catheter | LOX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231402 | 2023-12-20 | LIT | Traditional | This company |
| K221245 | 2022-12-14 | LIT | Traditional | This company |
| K211349 | 2022-01-07 | LOX | Traditional | This company |
| K211393 | 2021-07-02 | LOX | Traditional | This company |
| K182699 | 2018-11-26 | LOX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Employees | 300 |
| Factory area | 10,000 square meters |
| Main products | Coronary stent systems, PTCA balloon catheters, Cardiac ablation catheters, PTA balloon catheters, Vena cava filters |
| Certifications | ISO 9001, ISO 13485, GMP, CE, FDA, KFDA, PMDA |
| Export markets | North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Middle East, Eastern Asia, Western Europe |
| 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.