Shenzhen Dongdixin Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 18 device types, 5 products catalogued, 26 clearances.
Shenzhen Dongdixin Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Device, Biofeedback and 16 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3005170249 |
| FEI number | 3005170249 |
| DUNS | 545301488 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市东迪欣科技有限公司 |
|---|---|
| Unified social credit code | 91440300715275040J |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District, |
| Postal code | 518108 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Caretalk | FLL | 2 |
| Little Journey | FLL | 2 |
| Philips Avent ear thermometer | FLL | 1 |
| Welby | NGX | 1 |
| Philips ear thermometer | FLL | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260412 | 2026-06-26 | NUH | Traditional | This company |
| K240358 | 2024-06-05 | ISA | Traditional | This company |
| K213043 | 2022-02-25 | IPF | Traditional | This company |
| K210364 | 2021-06-17 | PCC | Traditional | This company |
| K180331 | 2018-06-22 | NUH | Traditional | This company |
| K171430 | 2018-03-15 | KPI | Traditional | This company |
| K173462 | 2017-12-08 | NUH | Special | This company |
| K171978 | 2017-10-02 | IPF | Traditional | This company |
| K162479 | 2017-02-08 | NUH | Traditional | This company |
| K161735 | 2016-11-17 | FLL | Traditional | This company |
| K150436 | 2015-11-13 | IMG | Traditional | This company |
| K142976 | 2015-08-26 | IMI | Traditional | This company |
| K141076 | 2014-11-14 | GXY | Traditional | This company |
| K133965 | 2014-06-16 | NGX | Traditional | This company |
| K131899 | 2014-03-14 | IMJ | Traditional | This company |
| K131259 | 2013-12-27 | ILY | Traditional | This company |
| K130802 | 2013-09-16 | NUH | Traditional | This company |
| K120217 | 2012-11-21 | IMG | Traditional | This company |
| K110707 | 2011-08-03 | NUH | Traditional | This company |
| K100488 | 2010-07-22 | FLL | Traditional | This company |
| K093138 | 2010-02-12 | IPF | Traditional | This company |
| K100117 | 2010-01-29 | IPF | Traditional | This company |
| K092627 | 2010-01-14 | IMG | Traditional | This company |
| K082057 | 2009-02-26 | GZJ | Traditional | This company |
| K073366 | 2008-02-08 | FLL | Traditional | This company |
| K051251 | 2005-09-07 | FLL | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Infrared thermometers, Pain relief devices, TENS, EMS, Light therapy |
|---|---|
| Certifications | ISO 13485, CE0197 |
| 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.