Shanghai Bele Medical Technology Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 3 device types, 2 products catalogued, 3 clearances.
Shanghai Bele Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Laser For Disruption Of Adipocyte Cells For Aesthetic Use and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027619554 |
| FEI number | 3027619554 |
| DUNS | 724477410 |
| Establishment type | Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District |
| Postal code | 201600 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | Class 2 | Diode Laser Body Sculpture Systems(BL-A10) | 2023 | 7 |
| Powered Laser Surgical Instrument | Class 2 | Multi-function Platform Systems(BL-M10), Picosecond ND:YAG laser system(BL-C10) | 2024 | 92 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class 2 | Multi-function Platform Systems(BL-M10) | 2024 | 31 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240474 | 2024-05-20 | GEX | Traditional | This company |
| K240386 | 2024-05-16 | GEX | Traditional | This company |
| K231131 | 2023-06-22 | PKT | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Diode laser hair removal, Picosecond Nd:YAG laser, Fractional fiber laser, Multi-function platform device, CO2 laser |
|---|---|
| Certifications | ISO 13485, CE, FDA 510K, TGA, Anvisa, RoHS |
| Export markets | USA, UK, France, Brazil |
| 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.