Medcodes Healthcare (Shenzhen) Limited
Registered establishment in Shenzhen, Guangdong, China. 9 device types.
Medcodes Healthcare (Shenzhen) Limited is a manufacturer holding a current FDA establishment registration. The registration covers Toothbrush, Powered, Irrigator, Powered Nasal and 7 other device types. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | MEDCODES HEALTHCARE (SHENZHEN) LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3025428426 |
| FEI number | 3025428426 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 美康迪医疗(深圳)有限公司 |
|---|---|
| Unified social credit code | 91440300MA5HF0LE1K |
| Source | provincial manufacturer licence lists |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 401, Building A, No.6 of Xinmu Road, Xinmu Community, Pinghu |
| Postal code | 518111 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | Class 1 | Warming Massage Cleaning Silicon Facial Brush SK0310, Silicon Facial Cleansing Brush SK0308, Heating FACIAL CLEANSING BRUSH, XPRE430 | 2025 | 65 |
| Heat Source For Bleaching Teeth | Class 1 | Teeth Whitening Strip WS301, WS401, medcodes W10, medcodes W20, medcodes W30, medcodes W40, Teeth Bleaching Light W1001, W3001, W4002, W4003, W4009,W4019,W4011,W4018,W4010,W4017,W4015,W4016,W4260,W4280 | 2022 | 56 |
| Irrigator, Powered Nasal | Class 1 | Electric Nasal Irrigator N5201, N5202, N5260, N8001, N5280 medcodes F3, H5601, N5262, N5290, H5602, M7901 | 2022 | 63 |
| Massager, Therapeutic, Electric | Class 1 | Queenwill KK-11; Queenwill H01; Queenwill H01B, Massager: YX-710 | 2024 | 437 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | Electric Nasal Aspirator NASA608, Baby Nasal Aspirator NASA009 | 2025 | 14 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | EMS Foot Massager MH-1019 | 2025 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | EMS Foot Massager MH-1019 | 2025 | 57 |
| Syringe, Irrigating (Non Dental) | Class 1 | Electric Ear Waxremoval Device 2415 | 2025 | 110 |
| Toothbrush, Powered | Class 1 | Sonic Electric Toothbrush L1, Sonic electric toothbrush X-3 | 2025 | 191 |
Clearances
No clearance names Medcodes Healthcare (Shenzhen) Limited as applicant. 3 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 |
|---|---|---|---|---|
| K244033 | 2025-05-16 | BTA | Traditional | Shenzhen Desida Technology Co., Ltd. |
| K241678 | 2024-09-09 | NUH | Traditional | Shenzhen Minghuangda Electronics Co., Ltd. |
| K233901 | 2024-03-20 | BTA | Traditional | Shenzhen Desida Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Nasal irrigators, Oral irrigators, Respiratory health products, Home medical devices, Teeth whitening products |
|---|---|
| Certifications | ISO9001, ISO13485, CE, FCC, ETL |
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.