Data / Medical devices / China / Taian Dalu Medical Instrument Co.,ltd.
Taian Dalu Medical Instrument Co.,ltd.: FDA-registered device maker in Taian Shandong, China, 1 510(k) clearance
Taian Dalu Medical Instrument Co.,ltd. is registered with the FDA (registration 3014335097) in Taian Shandong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014335097
- Address
- No.3988 Yitianmen Street, Hi-tech Zone, Taian Shandong, China, 271000
- Owner or operator
- Taian Dalu Medical Instrument Co.,Ltd. (10061508)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- January 29, 2024
- Registered through
- 2026
- Brand names listed
- DL-DF01, Electronic Peak Flow Meter, FPF-S1, Nose clip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Nose | BXJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2024 | K230423 | Electronic Peak Flow Meter | BZH | Substantially Equivalent | Taian Dalu Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.