Data / Medical devices / China / Auckland Medical Polymer (Tianjin) Co., Ltd
Auckland Medical Polymer (Tianjin) Co., Ltd: FDA-registered device maker in Tianjin, China, 1 510(k) clearance
Auckland Medical Polymer (Tianjin) Co., Ltd is registered with the FDA (registration 3011559089) in Tianjin, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2020. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3011559089
- Address
- Bldg D5-2 XEDA International Industrial Park Xiqing Economic Development Area, Tianjin, China, 300385
- Owner or operator
- Auckland Medical Polymer (Tianjin) Co., Ltd (10048110)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 9, 2014
- Registered through
- 2027
- Brand names listed
- Finger Traps Traction Strap Accessories Traction, OKLand Adjustable Stirrups for Lithotomy Surgery, OKLand Disposable Face Shield, OKLand Gel Pads, OKLand Patient Return Electrode Pad, OKLand Protective Goggle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Traction | ILZ | 1 | Manufacturer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | 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 |
|---|---|---|---|---|---|---|
| February 4, 2020 | K183148 | OKLand Patient Return Electrode Pad | GEI | Substantially Equivalent | Auckland Medical Polymer(Tianjin) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Support, Patient Position
- All makers of Protector, Skin Pressure
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Accessory, Surgical Apparel
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Accessories, Traction
Updated February 4, 2020. 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.