Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038613041

FEI Number

3038613041

Entity Name

EVOCARE PTE. LTD.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

346C KING GEORGE'S AVENUE, KING GEORGE'S BUILDING, Singapore Central Singapore 208577, SG

Establishment Type(s)

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

Owner / Operator

EVOCARE PTE. LTD. (Owner Number: 10093428)

Owner / Operator Contact Address

346C KING GEORGE'S AVENUE, KING GEORGE'S BUILDING, SINGAPORE 208577, Singapore, SG-NOTA 208577, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Infrared Body Thermometer,Model:H8831US Upside Down Peri Bottle, Model: K5101US; Peri Bottle, Model: K5102US No Touch Forehead Thermometer,Model:BNT100US No Touch Forehead Thermometer,Model:BNT100US,VNT200US Electric Nasal Aspirator,Model:HTD2601US, HTD2602US, H2603US, H2605US, H2606US, H2609AU, H2609US Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A,VNT275US Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A Postpartum Catch-All Pads, Model: K5501US; Postpartum Pads, Model: K5502US Infrared Body Thermometer,Model:HTD8220US Behind-the-Ear Hearing Aid, model: HTD6102US Instant Ice Maxi Pads, Postpartum Ice Pack Pads, Model: K5201US, K5202US

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	2025-05-14
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2025-05-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-05-14
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-06-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-05-14
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2025-05-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-05-14
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2025-06-11
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-05-14

Official Correspondent

Haiping Tan

US Agent Details

Hui Hong Business: ABMED SERVICE INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

EVOCARE PTE. 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-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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 3038613041. Last updated year: 2026. Please use registration number 3038613041 when referencing this establishment in official correspondence.