Gemtier Medical (Shanghai) Inc.
Manufacturer and brand owner in Shanghai, China. 4 device types, 1 product catalogued, 5 clearances.
Gemtier Medical (Shanghai) Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Syringe, Antistick and 2 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
4device types registered with the FDA
1product
5510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009746425 |
| FEI number | 3009746425 |
| DUNS | 529511052 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海金塔医用器材有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 18, Jianding Road, Fengjing Town, |
| Postal code | 201502 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | Class 2 | Safety Blood Collection Device for Single Use, Reli, Sterile Syringe with Safety needle for Single Use, Sterile Safety Needle for Single Use, Sterile Syringe for Single Use | 2017 | 71 |
| Set, Administration, Intravascular | Class 2 | Safety Blood Collection Device for Single Use, Reli | 2017 | 49 |
| Syringe, Antistick | Class 2 | Sterile Syringe with Safety needle for Single Use, Sterile Safety Needle for Single Use, Sterile Syringe for Single Use | 2020 | 39 |
| Syringe, Piston | Class 2 | Sterile Syringe with Safety needle for Single Use, Sterile Safety Needle for Single Use, Sterile Syringe for Single Use | 2020 | 60 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Gemtier | MEG | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212652 | 2022-03-02 | MEG | Traditional | This company |
| K202493 | 2021-02-04 | FXX | Traditional | This company |
| K202331 | 2021-02-02 | FXX | Traditional | This company |
| K192679 | 2020-04-10 | MEG | Traditional | This company |
| K170276 | 2017-12-11 | FMI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1988 |
|---|---|
| Employees | 550 |
| Main products | Blood collection sets, Infusion pumps, Safety syringes, Anesthesia equipment |
| Certifications | ISO9001, ISO13485, CE, FDA |
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.