Taian Dalu Medical Instrument Co., Ltd.
Registered establishment in Taian, Shandong, China. 2 device types, 1 clearance.
Taian Dalu Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clip, Nose, Meter, Peak Flow, Spirometry. Its earliest product listing with the FDA dates from 2024.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | TAIAN DALU MEDICAL INSTRUMENT CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014335097 |
| FEI number | 3014335097 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 泰安大陆医疗器械有限公司 |
|---|---|
| Unified social credit code | 9137090056405061XL |
| Source | NMPA UDI database |
Location
| City | Taian |
|---|---|
| Province | Shandong |
| Address | No.3988 Yitianmen Street, Hi-tech Zone |
| Postal code | 271000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clip, Nose | Class 1 | Nose clip | 2024 | 17 |
| Meter, Peak Flow, Spirometry | Class 2 | DL-DF01, Electronic Peak Flow Meter, FPF-S1 | 2024 | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230423 | 2024-02-23 | BZH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | Spacer for aerosol, Dry powder inhalers, MDI actuators, Nebulizers, Asthma/COPD devices |
| Certifications | CE, ISO13485 |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Kangsheng Medical Devices 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.