Shenzhen Delica Medical Equipment Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 5 device types, 4 products catalogued, 3 clearances.
Shenzhen Delica Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Blood Pressure Cuff, Transducer, Ultrasonic, Diagnostic and 3 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2006.
Registration
| Registered name | SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006441164 |
| FEI number | 3006441164 |
| DUNS | 544412009 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳德力凯医疗电子股份有限公司 |
|---|---|
| Unified social credit code | 91440300708451536R |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 18F, Building B, High-tech park, Guangqiao Road, Tianliao Community, |
| Postal code | 518107 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Transcranial Doppler Ultrasound System | 2019 | 50 |
| Diagnostic Ultrasonic Transducer, Robotic | Class 2 | Transcranial Doppler Ultrasound System | 2010 | 1 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | Transcranial Doppler Ultrasound System | 2006 | 22 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Transcranial Doppler Ultrasound System | 2019 | 98 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Transcranial Doppler Ultrasound System | 2006 | 44 |
Own-Brand Listings
Clearances
3 clearances name Shenzhen Delica Medical Equipment Co., Ltd. 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 |
|---|---|---|---|---|
| K213009 | 2022-07-08 | IYN | Traditional | This company |
| K190228 | 2019-06-13 | IYN | Traditional | This company |
| K173801 | 2018-07-11 | IYN | Special | This company |
| K122710 | 2013-02-15 | IYN | Special | Shenzhen Delicate Electronics Co., Ltd. |
| K092164 | 2010-05-13 | OQQ | Traditional | Shenzhen Delicate Electronics Co., Ltd. |
| K060112 | 2006-05-05 | IYN | Traditional | Nodecrest, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Main products | EEG digital brain electrode systems, TMS transcranial magnetic stimulation, TCD ultrasound transcranial Doppler, MVU multi-function vascular ultrasound, NICP non-invasive intracranial pressure detection |
| Certifications | National High-Tech Enterprise, TÜV ISO 13485, SGS ISO 13485, EU CE certification, US FDA certification |
| Export markets | 30+ countries and regions |
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.