Dalian Labtek Science & Development Co Ltd
Registered establishment in Dalian, Liaoning, China. 1 device type, 3 clearances.
Dalian Labtek Science & Development Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Sleeve, Limb, Compressible. Its earliest product listing with the FDA dates from 2012.
1device type
3510(k) clearances
Registration
| Registered name | DALIAN LABTEK SCIENCE & DEVELOPMENT CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010148613 |
| FEI number | 3010148613 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 莱博泰克（大连）科技有限公司 |
|---|---|
| Unified social credit code | 91210213792008958K |
| Source | NMPA UDI database |
Location
| City | Dalian |
|---|---|
| Province | Liaoning |
| Address | 1-18-17, Liandong Street, Advanced Equipment Manufacturing Industry Park |
| Postal code | 116021 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Sleeve, Limb, Compressible | Class 2 | Veinoflow SCD, Model LBTK-M-I 5001, Veinoflow SCD, LBTK-M-I 5006, A-V Hand&Foot Pump, Model LBTK-M-I 1000 | 2012 | 24 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213313 | 2022-02-09 | JOW | Traditional | This company |
| K123830 | 2013-08-16 | JOW | Traditional | This company |
| K121718 | 2012-08-17 | JOW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | Arteriovenous foot pump, Antithrombotic pump, Pneumatic compression therapy device, Visualized laryngoscope, Sputum evacuation machine |
| Certifications | FDA, CE, ISO 9001, ISO 13485, TÜV |
| Export markets | 50 countries including US, Germany, UK, Korea, Saudi Arabia, South Africa, Brazil |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Goodwood Medical Care Ltd | 19 |
| Dalian Rongbang Medical Healthy Devices Co Ltd | 15 |
| Omron (Dalian) Co., Ltd. (Plant 1) | 7 |
| Dalian Wenjing Wooden Industry Co., Ltd. | 6 |
| NiTec Eyewear (Dalian) Inc. | 4 |
| Dalian Sundly Home Products Co., Ltd. | 3 |
| Dalian Jiaxing Plastic Co., Ltd. | 2 |
| Dalian Create Medical Products Co., Ltd. | 2 |
| Dalian Orientech Co., Ltd. | 1 |
| Dalian Sportech Apparel Co., Ltd. | 1 |
| Dalian Latex Co Ltd | 1 |
| Takara Biotechnology (Dalian) Co., Ltd. | 1 |
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.