Auckland Medical Polymer (Tianjin) Co., Ltd.
Registered establishment in Tianjin, China. 6 device types, 1 clearance.
Auckland Medical Polymer (Tianjin) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Accessories, Traction, Protector, Skin Pressure and 4 other device types. Its earliest product listing with the FDA dates from 2014.
6device types registered with the FDA
1510(k) clearance
Registration
| Registered name | Auckland Medical Polymer (Tianjin) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011559089 |
| FEI number | 3011559089 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 奥克兰高分子医用材料（天津）有限公司 |
|---|---|
| Unified social credit code | 911201117972552377 |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | Bldg D5-2 XEDA International Industrial Park |
| Postal code | 300385 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Traction | Class 1 | Finger Traps Traction Strap Accessories Traction | 2023 | 5 |
| Accessory, Surgical Apparel | Class 1 | OKLand Disposable Face Shield | 2020 | 439 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | OKLand Patient Return Electrode Pad | 2020 | 65 |
| Protector, Skin Pressure | Class 1 | OKLand Gel Pads | 2014 | 101 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | OKLand Protective Goggle | 2020 | 384 |
| Support, Patient Position | Class 1 | OKLand Adjustable Stirrups for Lithotomy Surgery | 2015 | 66 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K183148 | 2020-02-04 | GEI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Factory area | 10,000 m² |
| Main products | Gel pads positioners, Stirrups, Electrode pads, PPE |
| Certifications | CE, FDA, ISO 13485:2016, MDSAP, RoHS |
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.