Elite Medtek(Jiangsu) Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 9 device types, 2 products catalogued.
Elite Medtek(Jiangsu) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Lavage, Jet, Tourniquet, Nonpneumatic and 7 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
9device types registered with the FDA
2products catalogued under its own name
Registration
| Registered name | ELITE MEDTEK(JIANGSU) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012964172 |
| FEI number | 3012964172 |
| DUNS | 542974341 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江苏爱芮斯医疗科技有限责任公司 |
|---|---|
| Unified social credit code | 913204120844441180 |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 5, Tianning Zhizao Park, No. 5 Beitanghe East Road, Tianning District |
| Postal code | 213003 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | face shield | 2020 | 439 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | Maniflods, stopcock, adaptor | 2019 | 13 |
| Angiography/Angioplasty Kit | Class 2 | Inflation kit | 2019 | 3 |
| Bottle, Collection, Vacuum | Class 2 | ProTrap LumaTM Polyp Trap Specimen Tray, ProTrap LumaTM In-Line Polyp Trap | 2021 | 88 |
| Instrument, Ent Manual Surgical | Class 1 | E 01 3591, inflation device, EM-ID-M14S, E 01 3591S | 2020 | 11 |
| Lavage, Jet | Class 2 | Disposable Inflation Device | 2025 | 17 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Medical Isolation Eye Mask | 2020 | 384 |
| Syringe, Balloon Inflation, Exempt | Class 2 | Inflation Device, Model EM-lD-D40S, Inflation Device, Model EM-lD-M30S, Inflation Device, Model EM-lD-M40S, Inflation Device, Model EM-lD-D40, Inflation Device, Model EM-lD-D30, Inflation Device, Model EM-lD-M30 and 11 more | 2017 | 16 |
| Tourniquet, Nonpneumatic | Class 1 | Radial artery tourniquet | 2019 | 124 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Elite Medtek | PTM | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Factory area | 700 m² |
| Main products | Intervention medical devices, Radial artery tourniquets, Catheter connectors, Inflation devices, Sinus balloons |
| Certifications | ISO 13485, CE |
| OEM and ODM | Offered |
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.
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