Changchun AIK Medical Devices Co., Ltd.
Manufacturer and brand owner in Changchun, Jilin, China. 1 device type, 3 products catalogued, 1 clearance.
Changchun AIK Medical Devices Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Needle, Acupuncture, Single Use. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
1device type
3products catalogued under its own name
1510(k) clearance
Registration
| Registered name | CHANGCHUN AIK MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013950830 |
| FEI number | 3013950830 |
| DUNS | 543439762 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 长春爱康医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 91220181668739841R |
| Source | NMPA UDI database |
Location
| City | Changchun |
|---|---|
| Province | Jilin |
| Address | No. 1188, jia ‘er road, jiutai economic development zone, Changchun |
| Postal code | 130507 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | Class 2 | KMA, Aik | 2017 | 33 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sterile Acupuncture Needles FOR Single USE | MQX | 397 |
| BON Spring Needles | MQX | 18 |
| KMA | MQX | 12 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K162566 | 2017-05-11 | MQX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Main products | Single-use sterile acupuncture needles, Press needles, Blade needles, Skin roller needles |
| Certifications | ISO 13485, EU CE, South Korean GMP, Canadian CMDCAS, US FDA, MDSAP, EU MDR |
| Export markets | International (New Third Board listed company) |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Dirui Industrial Co., Ltd. | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | 24 |
| Changchun LYZ Technology Co., Ltd. | 16 |
| Jilin Test BIO-Electron Co., Ltd. | 9 |
| Sincera Technology (Changchun) Co., Ltd. | 2 |
| Sino-Dentex Co., Ltd. | 2 |
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.