Zhuhai Linte Medical Instrument Co., Ltd.
Registered establishment in Zhuhai, Guangdong, China. 3 device types, 2 clearances.
Zhuhai Linte Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Oximeter, Infrared, Sporting, Aviation and 1 other device type. Its earliest product listing with the FDA dates from 2019.
3device types registered with the FDA
2510(k) clearances
Registration
| Registered name | ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016170326 |
| FEI number | 3016170326 |
| Establishment type | Manufacturer |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | 501, Building #3, 2 Jinliang Road, Hongqi Town, Jinwan District |
| Postal code | 519090 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Oximeter | Class 2 | Fingertip Pulse Oximeter (model: LT-F20, LT-F30, LT-F50, LT-F60, LT-F70, LT-F80, LT-F90, LT-F21, LT-F31, LT-F51), Fingertip Pulse Oximeter (model: LT-F61, LT-F71, LT-F81, LT-F91) | 2021 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | AS series pulse oximeter: LT-AS series, Fingertip pulse oximeter: LT-F series, LT-F20, LT-F21, LT-F30, LT-F31, LT-F50, LT-F51, LT-F60, LT-F61, Handheld pulse oximeter: LT-H series | 2019 | 29 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Blood Pressure Monitor/ Model: LT-P30, LT-P30A, LT-P31, LT-P31A, LT-P35, LT-P50, LT-P51, LT-P70, LT-P71, Blood Pressure Monitor/ Model: PH-PMDBPAMP, Brand Name: Proheal, Upper Arm Blood Pressure Monitor/ Model: BU 420, Brand Name: Medisana | 2022 | 98 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220220 | 2022-10-03 | DXN | Traditional | This company |
| K210274 | 2021-07-30 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Smart medical products, Medical instruments |
|---|---|
| Certifications | FDA approval |
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.
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