Data / Medical devices / China / Yiwu Ori-Power Medtech Co., Ltd.
Yiwu Ori-Power Medtech Co., Ltd.: FDA-registered device maker in YIWU Zhejiang, China, 2 510(k) clearances
Yiwu Ori-Power Medtech Co., Ltd. is registered with the FDA (registration 3012309743) in YIWU Zhejiang, China. It lists 46 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 23, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012309743
- Address
- No.86 Xiahe Road, Beiyuan Street, Yiwu, YIWU Zhejiang, China, 322000
- Owner or operator
- Yiwu Ori-Power Medtech Co.,Ltd. (10051297)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- March 1, 2016
- Registered through
- 2027
- Brand names listed
- Adhesive Eye Pad, Alcohol Prep Pad, BANDAGE, BZK Antiseptic Swab/Antiseptic Cleaning Wipes-Sting Free, Cold Pad, Cotton Swabs, DRESSING, Disposable Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Airway, Nasopharyngeal | BTQ | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Beads, Hydrophilic, For Wound Exudate Absorption | KOZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crimper, Pin | HXQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Iodine (Tincture) | IAL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Kit, First Aid, Talking | OVR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nursing Pad, Hydrogel | NTC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Solution, Isotonic | JCE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stretcher, Patient Restraint | NZD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US, 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 |
|---|
| April 23, 2021 | K210007 | Face Mask | FXX | Substantially Equivalent | Jinhua Jingdi Medical Supplies Co., Ltd. | accessdata.fda.gov |
| December 13, 2010 | K102718 | DIGITAL THERMOMETER; DIGITAL THERMOMETER | FLL | Substantially Equivalent | International Regulatory Consultants, LLC (Irc) | accessdata.fda.gov |
Compare with other makers
Updated April 23, 2021. 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.