Shenzhen Creative Industry Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 9 device types, 7 products catalogued, 11 clearances.
Shenzhen Creative Industry Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Oximeter, Wellness and 7 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
9device types registered with the FDA
7products catalogued under its own name
11510(k) clearances
Registration
| Registered name | SHENZHEN CREATIVE INDUSTRY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006733253 |
| FEI number | 3006733253 |
| DUNS | 547908801 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市科瑞康实业有限公司 |
|---|---|
| Unified social credit code | 914403007152614151 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road |
| Postal code | 518110 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | Patient Monitor, UP-7000, K10, K12, K15, i120, i150 | 2013 | 29 |
| Continuous Measurement Thermometer | Class 2 | Handheld Pulse Oximeter, SP-20, All-in-One Health Monitor, PC-303, Patient Monitor, K10, K12, K15, i120, i150 | 2017 | 115 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | Patient Monitor, UP-7000, All-in-One Health Monitor, PC-303, K10, K12, K15, i120, i150 | 2013 | 17 |
| Oximeter | Class 2 | Fingertip Oximeter, PC-60NW, PC-60FW, Pulse Oximeter, AP-10, Handheld Pulse Oximeter, SP-20 and 7 more | 2007 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | KS-60A, Pulse Oximeter, PC-66L W72, KS-60F, KS-60FW, KS-60FB, KS-60FWB, KS-2, KS-60NW, KS-60NWB, S5, S5W, S5B, S5WB, S5G, S5WG | 2011 | 29 |
| Oximeter, Wellness | Class 2 | Wellness Oximeter, KW-68B, PC-66H, PC-66L, Oxyknight Watch, OxyKnight Watch Lite, PC-60B1 | 2015 | 19 |
| Recorder, Magnetic Tape, Medical | Class 2 | ECG Monitor, PC-80, All-in-One Health Monitor, PC-303 | 2008 | 4 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Patient Monitor, UP-7000, All-in-One Health Monitor, PC-303, K10, K12, K15, i120, i150 | 2013 | 98 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | All-in-One Health Monitor, PC-303 | 2017 | 20 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Pulse Oximeter | DQA | 14 |
| Pulse Oximeter | OCH | 13 |
| Pulse Oximeter | PGJ | 3 |
| Patient Monitor | MWI | 1 |
| Easy ECG Monitor | DSH | 1 |
| All-in-One Health Monitor | DSH | 1 |
| Handheld Pulse Oximeter | FLL | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K201468 | 2021-01-25 | DQA | Traditional | This company |
| K192343 | 2019-12-31 | DQA | Traditional | This company |
| K172792 | 2018-11-13 | DQA | Traditional | This company |
| K170047 | 2017-09-09 | MWI | Traditional | This company |
| K150093 | 2015-06-03 | DQA | Special | This company |
| K123711 | 2013-10-01 | MWI | Traditional | This company |
| K120502 | 2012-12-07 | DQA | Abbreviated | This company |
| K093016 | 2010-03-30 | DQA | Traditional | This company |
| K082055 | 2009-02-06 | KNG | Traditional | This company |
| K073152 | 2008-01-10 | DSH | Traditional | This company |
| K063641 | 2007-07-13 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | ECG machines, Patient monitors, Pulse oximeters |
| Certifications | ISO9001, CE, FDA |
| 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.