Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007703436

FEI Number

3007703436

Entity Name

WENZHOU CARETEK MEDICAL DEVICE CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

Room 1301.Yue Shang Mansion.Nanhui.Lucheng., Wenzhou Zhejiang 325000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Wenzhou Caretek Medical Device Co., Ltd (Owner Number: 10029464)

Owner / Operator Contact Address

Room 1301.Yue Shang Mansion.Nanhui.Lucheng., Wenzhou, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Infrared forehead thermometer Digital Thermometer Non-surgical protective gown Digital thermometer Infrared thermometer Digital thermometer Surgical Hammer Stethoscope stainless steel stethoscope,single head,dual head,spraugue rappaport stethoscope,cardiology type Irrigator Retractor Chair Scale Strecher Scale Weighmobile Baby Scale Digital Thermometer Digital Blood Pressure Monitor Pressure Infusion Bag Sensory Testing Monofilament;Testing Monofilament Otoscope tips Otoscope Penlight Plastic bottle Blade Goniometer Caliper Hot water bottle Digital Blood Pressure Monitor System, measurement, blood-pressure, non-invasive Nasal Syringe Digital Thermometer Hammer Tourniquet exercise feedback First Aid EMT kit Aneroid Sphygmomanometer with stethoscope Aneroid Sphygmomanometer Otoscope tips Otoscope BLOOD PRESSURE CUFF 3 Protective Mask Digital Thermometer Disposable CPR Face Shield Disposable Keyring CPR Face Shield Disposable CPR Mask Clinical electronic thermometer Infrared thermometer blood pressure cuff Aneroid Sphygmomanometer Aneroid Sphygmomanometer with stethoscope Shears

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	2016-12-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2009-10-09
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-11-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-03-01
GWZ	Percussor	Neurology	Class 1	882.1700	2016-08-22
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2009-05-19
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2017-12-21
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-12-19
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2023-11-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-10-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-12-21
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2016-07-14
GXB	Esthesiometer	Neurology	Class 1	882.1500	2016-08-16
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-10-09
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2009-10-09
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2015-08-04
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2009-10-09
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2021-05-27
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2011-12-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-05-18
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2021-06-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-25
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-10-09
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2009-10-09
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2023-08-09
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2022-07-25
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2023-07-06
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-07-06
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-10-09
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2011-03-04
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2009-10-09
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-08-07
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-08
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2009-05-18
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2021-11-30
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2009-10-09

Official Correspondent

Yuan Huang

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Wenzhou Caretek Medical Device 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-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

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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 3007703436. Last updated year: 2026. Please use registration number 3007703436 when referencing this establishment in official correspondence.