Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011713222

FEI Number

3011713222

Entity Name

Shenzhen Caremed Medical Technology Co.,Ltd.

City/State/Country

shenzhen Guangdong, CN

Establishment Address

3/F, Building C, Xiazao Digital Industrial Park, No. 8 Huali Road, Gaofeng Community, Dalang office, Longhua District, Shenzhen, shenzhen Guangdong 518109, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Caremed Medical Technology Co.,Ltd. (Owner Number: 10049378)

Owner / Operator Contact Address

3/F, Building C, Xiazao Digital Industrial Park, No. 8 Huali Road, Gaofeng Community,Dalang Office,Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153184

PMA Number

N/A

All Registered Proprietary Names

Caremed Reusable Temperature Probe Caremed Disposable Temperature Probe C503-16 C533-16 C543-16 C523-16 C503-01 C503-49 853030005 H8-CF103 H8-CF101 Disposable ECG cable KM-82080 Caremed Diaposable Abdominal belt Caremed resuable Abdominal belt Dispoable face mask SA30S-91 Caremed compatible oximeter sensors,Caremed Reusable & Disposable SpO2 Sensors C803-01X SA10B-127 SA30B-02 C410B-15R SA30B-21 C410B-153R SA30B-07 C803-49R SA36B-15R SA30B-29 C403B-49R SA30B-20 SA15B-91 SA10B-08 C410-21X SA30B-48R SA20B-91 C103F-49R SA30B-21R SA30B-75 SA30B-43X SA10B-01 SA30B-48 SA30B-09 C403S-49R C903-91 SA30B-91 SA20B-08 C403S-15 SA15B-49R SA30B-08 SA10B-75 C403B-117 C403-01 C403B-01X SA30B-300 SA36B-15* C430B-146D SA30B-01X SA30C-01X SA30Y-01X N543-01 SA36B-15

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	2015-05-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-12-28
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-09-25
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2015-05-22
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-05-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen Caremed Medical Technology 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
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04
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

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

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011713222. Last updated year: 2026. Please use registration number 3011713222 when referencing this establishment in official correspondence.