Data / Medical devices / China / Pinghu Sama Medical Packing Co., Ltd.
Pinghu Sama Medical Packing Co., Ltd.: FDA-registered device maker in Pinghu Zhejiang, China, 3 510(k) clearances
Pinghu Sama Medical Packing Co., Ltd. is registered with the FDA (registration 3010521050) in Pinghu Zhejiang, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 15, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010521050
- Address
- 1 Qunfeng Road, South of Lindai, Pinghu Zhejiang, China, 314202
- Owner or operator
- Pinghu Sama Medical Packing Co., Ltd. (10045154)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 23, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Stomal | GDS | 1 | Manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, 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 15, 2016 | K152690 | DISPOSABLE THERMOMETER PROBE SHEATHS | FLL | Substantially Equivalent | Pinghu Sama Medical Packing Co., Ltd. | accessdata.fda.gov |
| April 2, 2015 | K150227 | Disposable Blood Pressure Cuff Guard | DXQ | Substantially Equivalent | Pinhu Sama Medical Packing Co., Ltd. | accessdata.fda.gov |
| September 19, 2014 | K141998 | SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS | DXQ | Substantially Equivalent | Pinghu Sama Medical Packing Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Pressure Cuff
- All makers of Continuous Measurement Thermometer
- All makers of Bag, Stomal
- All makers of Instrument, Manual, Surgical, General Use
Updated January 15, 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.