Data / Medical devices / China / Shenzhen Narig Bio-Medical Technology Co., Ltd.
Shenzhen Narig Bio-Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Narig Bio-Medical Technology Co., Ltd. is registered with the FDA (registration 3021962893) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 14, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021962893
- Address
- Room 516,Podium Building 12,shenzhen Bay Science and Technology Ecological Park,High-tech community No.18,Technology South road,Yuehai streest,Nanshan District,Shenzhen City, Shenzhen Guangdong, China, 518052
- Owner or operator
- Shenzhen Narig Bio-Medical Technology Co., Ltd. (10084192)
- Roles
- Manufacturer
- First device listed
- January 24, 2022
- Registered through
- 2026
- Brand names listed
- CF-100, CF-100A, CF-100B, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | 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 |
|---|---|---|---|---|---|---|
| January 14, 2022 | K211632 | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) | DQA | Substantially Equivalent | Shenzhen Narig Bio-Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter, Wellness
- All makers of Oximeter
- All makers of Oximeter, Infrared, Sporting, Aviation
Updated January 14, 2022. 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.