Data / Medical devices / China / Orich Medical Equipment (tianjin) Co., Ltd.
Orich Medical Equipment (tianjin) Co., Ltd.: FDA-registered device maker in Tianjin, China, 4 510(k) clearances
Orich Medical Equipment (tianjin) Co., Ltd. is registered with the FDA (registration 3009608361) in Tianjin, China. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 2, 2016. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009608361
- Address
- No 16 Cuiming Road Yat-Sen Scientific In Tianjin Economic Technological Developme, Tianjin, China, 301726
- Owner or operator
- ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. (10040720)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 10, 2012
- Registered through
- 2026
- Brand names listed
- DF-211H RADIOGRAPHIC X-RAY SYSTEM, Disposable Medical Mask, FS-500DDR, Intra OS DG, Intra Os 70, KN95 Mask, Medical Surgical Mask, N95 Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| December 2, 2016 | K152813 | FS-500DDR Medical Radiographic X-Ray System | KPR | Substantially Equivalent | Orich Medical Equipment (Tianjin) Co., Ltd. | accessdata.fda.gov |
| April 17, 2012 | K120034 | RADIOGRAPHIC X-RAY SYSTEM | KPR | Substantially Equivalent | Orich Medical Equipment (Tianjin Co., Ltd. | accessdata.fda.gov |
| June 24, 2005 | K051464 | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) | EHD | Substantially Equivalent | Planmeca Oy | accessdata.fda.gov |
| July 8, 2003 | K031118 | INTRAOS 70 | EHD | Substantially Equivalent | Blue X Imaging Srl | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Respirator, Surgical
- All makers of Accessory, Surgical Apparel
Updated December 2, 2016. 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.