Data / Medical devices / Paper, Obstetric Ph
Paper, Obstetric Ph (LNW): 21 FDA-registered makers in 3 countries
21 establishments in 3 countries are registered with the FDA to make Paper, Obstetric Ph (product code LNW, Class 1, 21 CFR 862.1550). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on September 30, 2003, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LNW
- Device class
- 1
- Regulation
- 862.1550
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| China | 16 |
| United States | 4 |
| India | 1 |
Makers of Paper, Obstetric Ph
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Merydi Bio-Tech Co., Ltd. | changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Wancheng Bio-Electron Co., Ltd. | Changchun Jilin, China | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Changchun LYZ Technology Co.,LTD | Changchun City Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genabio Diagnostics Inc | Bedford, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henso Medical (hangzhou) Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Hongyi Bio-Tech Co., Ltd. | Changchun Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Test Bio-Electron Co.,ltd | Changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditec Devices | Vasai(E), Thane, Maharashtra, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Essential Laboratory, Inc. | Brooklyn, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pangaea Technologies LLC | The Woodlands, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safecare Biotech(hangzhou)co.,ltd | Huzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen MK Health Care Product Co., Ltd. | XIAMEN Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang E-WAY Healthcare Co., Ltd. | Jiaxing Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 30, 2003. 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.