Shanghai Mekon Medical Devices Co., Ltd.
Registered establishment in Shanghai, China. 11 device types.
Shanghai Mekon Medical Devices Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Syringe, Piston, Ophthalmic Needle and 9 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | SHANGHAI MEKON MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012552122 |
| FEI number | 3012552122 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 上海脉康医疗用品有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 526, No. 697-3 Lingshi Road Shanghai China |
| Postal code | 200072 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Dispenser, Liquid Medication | Class 1 | oral syringe; oral dispensing syringe | 2021 | 86 |
| Low Dead Space Needle, Single Lumen, Hypodermic | Class 2 | OcuSafe® Needle;VitreJect® Safety Needle;Needle;LDS Needle, OcuSafe® Ophthalmic Needle; VitreJect® Ophthalmic Safety Needle; SteriCap® Safety Needle; | 2026 | 2 |
| Low Dead Space Piston Syringe | Class 2 | VitreJect® Syringes;VitreJect® Ophthalmic Syringes | 2026 | 5 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | 2019 | 9 |
| Needle, Hypodermic, Single Lumen | Class 2 | OcuJect Ophthalmic Needle Needle, OcuSafe® Ophthalmic Needle; VitreJect® Safety Ophthalmic Needle; SteriCap® Safety Ophthalmic Needle;, sterile insulin syringe for single use with needle(U-100), sterile hypodermic needle for single use, sterile insulin syringe for single use with needle(U-40), Sterile hypodermic syringe for single use with/without needle and 2 more | 2019 | 71 |
| Ophthalmic Needle | Class 2 | OcuSafe® Needle;VitreJect® Safety Needle;Needle;LDS Needle, OcuSafe® Ophthalmic Needle; VitreJect® Ophthalmic Safety Needle; SteriCap® Safety Needle; | 2026 | 2 |
| Ophthalmic Syringe | Class 2 | VitreJect® Syringes;VitreJect® Ophthalmic Syringes | 2026 | 3 |
| Set, Administration, Intravascular | Class 2 | UltraFlo-R Push Button Blood Collection Set | 2024 | 49 |
| Syringe, Piston | Class 2 | MiniLoad® Syringes, sterile insulin syringe for single use with needle(U-100), sterile hypodermic needle for single use, sterile insulin syringe for single use with needle(U-40), Sterile hypodermic syringe for single use with/without needle, VitreJect® Syringes;VitreJect® Ophthalmic Syringes | 2019 | 60 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Manual Vacuum-Assisted Blood Collection System | 2024 | 31 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | Blood Collecting Needles, UltraFlo-R Push Button Blood Collection Set | 2018 | 23 |
Clearances
No clearance names Shanghai Mekon Medical Devices Co., Ltd. as applicant. 8 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 |
|---|---|---|---|---|
| K242956 | 2024-10-25 | QNS | Special | Ocuject, LLC |
| K220458 | 2023-09-29 | JKA | Traditional | Innovative Health, LLC. |
| K230959 | 2023-09-14 | FMI | Traditional | Ocuject, LLC |
| K230372 | 2023-09-08 | QLY | Traditional | Ocuject, LLC |
| K212544 | 2021-10-13 | FMF | Special | Ocuject, LLC |
| K172763 | 2018-06-04 | JKA | Traditional | Zhejiang Kindly Medical Devices Co., Ltd. |
| K171518 | 2018-01-05 | BSP | Traditional | Zhejiang Kindly Medical Devices Co., Ltd. |
| K112057 | 2011-12-14 | FMF | Traditional | Shanghai Kindly Enterprise Dev. Group Co., |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Main products | Anesthesia needles, Blood collection needles, Cosmetic needles, Infusion products |
| Certifications | CE, ISO 13485, FDA 510K, MDSAP, TGA |
| Export markets | North America, Europe, Latin America, Africa, Australia |
| 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.
The manufacturer named here can complete this record.