SHENZHEN CREATIVE INDUSTRY CO., LTD

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 3006733253

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006733253
FEI Number
3006733253
Entity Name
SHENZHEN CREATIVE INDUSTRY CO., LTD
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, SHENZHEN Guangdong 518110, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SHENZHEN CREATIVE INDUSTRY CO., LTD (Owner Number: 9104865)
Owner / Operator Contact Address
1001, Building West, Lepu Tower, No.66 Xingke Road, Xili Community, Xili Street, Nanshan District, SHENZHEN, CN-GD 518055, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K073152
PMA Number
N/A

All Registered Proprietary Names

Handheld Pulse Oximeter, SP-20 FINGERTIP OXIMETER PC-60NW PC-60FW Patient Monitor K10, K12, K15 i120, i150 Patient Monitor UP-7000 All-in-One Health Monitor PC-303 Pulse Oximeter AP-10 ECG Monitor PC-80

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-11-13
DQA Oximeter Cardiovascular Class 2 870.2700 2018-11-13
DQA Oximeter Cardiovascular Class 2 870.2700 2012-12-15
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-04-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2020-04-07
DQA Oximeter Cardiovascular Class 2 870.2700 2020-04-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-04-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-11-04
DQA Oximeter Cardiovascular Class 2 870.2700 2013-11-04
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-11-04
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2013-11-04
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2017-09-10
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2017-09-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-09-10
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-09-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-09-10
DQA Oximeter Cardiovascular Class 2 870.2700 2017-09-10
DQA Oximeter Cardiovascular Class 2 870.2700 2021-01-25
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2008-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

SHENZHEN CREATIVE INDUSTRY CO., LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006733253. Last updated year: 2026. Please use registration number 3006733253 when referencing this establishment in official correspondence.
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