Hunan Accurate BIO-Medical Technology Co., Ltd.
Manufacturer and brand owner in Changsha, Hunan, China. 7 device types, 7 products catalogued, 6 clearances.
Hunan Accurate BIO-Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Perineometer and 5 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011353016 |
| FEI number | 3011353016 |
| DUNS | 421349331 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 湖南艾瑞特生物医疗科技有限公司 |
|---|---|
| Unified social credit code | 914301000813947335 |
| Source | NMPA UDI database |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District |
| Postal code | 410208 |
| Country | China |
What It Makes
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252601 | 2026-05-14 | KPI | Traditional | This company |
| K252748 | 2026-04-27 | HIR | Traditional | This company |
| K243049 | 2025-01-02 | DQA | Traditional | This company |
| K240808 | 2024-10-03 | DQA | Traditional | This company |
| K171241 | 2018-03-27 | DQA | Traditional | This company |
| K141105 | 2014-12-04 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Factory area | 40,000 square meters |
| Main products | Blood oxygen detection, Pulse oximeter, Sleep monitoring, Doppler fetal monitor, Nasal care devices |
| Certifications | CE, FDA, NMPA, ISO13485, ISO9001 |
| Export markets | Over 100 countries including Europe, North America, Latin America, Middle East, Asia |
| OEM and ODM | Offered |
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.
The manufacturer named here can complete this record.