Yiwu Ori-Power Medtech Co., Ltd.
Manufacturer and brand owner in Yiwu, Zhejiang, China. 46 device types, 5 products catalogued.
Yiwu Ori-Power Medtech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Pad, Eye and 44 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
46device types registered with the FDA
5products catalogued under its own name
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012309743 |
| FEI number | 3012309743 |
| DUNS | 560451976 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Yiwu |
|---|---|
| Province | Zhejiang |
| Address | No.86 Xiahe Road, Beiyuan Street, Yiwu, |
| Postal code | 322000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Nasopharyngeal | Class 1 | OP- First Aid Series, ORI Power | 2022 | 52 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Yiwu ORI-Power Medtech | 2018 | 186 |
| Bandage, Elastic | Class 1 | Triangular Bandage | 2016 | 280 |
| Beads, Hydrophilic, For Wound Exudate Absorption | Class 1 | Hydrophilic | 2016 | 7 |
| Bedding, Disposable, Medical | Class 1 | First Aid Blanket And Emergency Survival Blanket | 2016 | 308 |
| Continuous Measurement Thermometer | Class 2 | 2016 | 115 | |
| Cotton, Roll | Class 1 | Cotton Swabs | 2016 | 107 |
| Crimper, Pin | Class 1 | Safety Pin | 2016 | 7 |
| Depressor, Tongue, Non-Surgical | Class 1 | Yiwu ORI-Power Medtech | 2018 | 100 |
| Disinfectant, Medical Devices | Class 1 | BZK Antiseptic Swab/Antiseptic Cleaning Wipes-Sting Free | 2016 | 197 |
| Dispenser, Liquid Medication | Class 1 | Yiwu ORI-Power Medtech | 2018 | 86 |
| Dressing, Wound, Hydrophilic | Class 1 | Dressing | 2016 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Non-Adherent Pad/Non-Stick Pad | 2016 | 183 |
| Driver, Surgical, Pin | Class 1 | Yiwu ORI-Power Medtech | 2018 | 12 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask | 2020 | 182 |
| Fiber, Medical, Absorbent | Class 1 | Non-Adherent Pad/Non-Stick Pad | 2016 | 172 |
| First Aid Kit With Drug | Class N | Yiwu ORI-Power Medtech | 2018 | 57 |
| First Aid Kit Without Drug | Class 1 | Yiwu ORI-Power Medtech | 2018 | 132 |
| Forceps | Class 1 | Yiwu ORI-Power Medtech | 2018 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | GAUZE Dressing | 2016 | 266 |
| Instrument, Manual, Surgical, General Use | Class 1 | Instrument Cases/First Aid Case/Plastic Case | 2016 | 110 |
| Iodine (Tincture) | Class 1 | Iodine Prep Pad | 2016 | 5 |
| Kit, First Aid, Talking | Class 1 | First Aid Bag/First Aid Kit | 2016 | 18 |
| Lubricant, Patient | Class 1 | ORI Power, OP- First Aid Series | 2022 | 33 |
| Mask, Oxygen | Class 1 | Yiwu ORI-Power Medtech | 2018 | 126 |
| Mask, Surgical | Class 2 | Disposable Face Mask | 2026 | 125 |
| Mouthpiece, Breathing | Class 1 | First Response Medical Supplies | 2017 | 67 |
| Nursing Pad, Hydrogel | Class 1 | Trauma Pad | 2016 | 15 |
| Orthosis, Cervical | Class 1 | Yiwu ORI-Power Medtech | 2018 | 114 |
| Orthosis, Limb Brace | Class 1 | Yiwu ORI-Power Medtech | 2018 | 144 |
| Pack, Hot Or Cold, Disposable | Class 1 | Cold Pad | 2016 | 176 |
| Pad, Alcohol, Device Disinfectant | Class U | Alcohol Prep Pad | 2016 | 49 |
| Pad, Eye | Class 1 | Adhesive Eye Pad | 2016 | 100 |
| Radiographic Protective Glove | Class 1 | Gloves | 2016 | 30 |
| Respirator, Surgical | Class 2 | face mask | 2020 | 118 |
| Scissors, General, Surgical | Class 1 | Scissors | 2016 | 83 |
| Scissors, Medical, Disposable | Class 1 | Yiwu ORI-Power Medtech | 2018 | 36 |
| Sling, Arm | Class 1 | Sling/Arm Triangle Bandage, Cravat Bandage for Arms & Legs | 2026 | 126 |
| Solution, Isotonic | Class 1 | Yiwu ORI-Power Medtech | 2018 | 16 |
| Splint, Hand, And Components | Class 1 | Yiwu ORI-Power Medtech | 2018 | 144 |
| Splint, Traction | Class 1 | Yiwu ORI-Power Medtech | 2018 | 27 |
| Stretcher, Patient Restraint | Class 1 | Yiwu ORI-Power Medtech | 2018 | 20 |
| Support, Patient Position | Class 1 | Yiwu ORI-Power Medtech | 2018 | 66 |
| Tape And Bandage, Adhesive | Class 1 | Bandage | 2016 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | Ori-Power | 2016 | 124 |
| Tray, Surgical, Instrument | Class 1 | Tray, Surgical | 2016 | 105 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| OP – First aid series | OHO | 23 |
| OP – First aid series | BYP | 1 |
| OP – First aid series | OVR | 1 |
| OP – First aid series | KGX | 1 |
Clearances
No clearance names Yiwu Ori-Power Medtech Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210007 | 2021-04-23 | FXX | Traditional | Jinhua Jingdi Medical Supplies Co., Ltd. |
| K102718 | 2010-12-13 | FLL | Traditional | International Regulatory Consultants, LLC (Irc) |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Factory area | 15000 |
| Main products | First aid kits, Survival kits, Elastic bandages, Surgical tapes, Gauze products |
| Certifications | EU TUV CE, ISO13485, FDA, BSCI |
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.