SIGMA-CARE DEVELOPMENT CO., LTD.

FDA Device Registration & Listing · Dalin Township, Chiayi County, TW · Registration 3003770834

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
3003770834
FEI Number
3003770834
Entity Name
SIGMA-CARE DEVELOPMENT CO., LTD.
City/State/Country
Dalin Township, Chiayi County, TW
Establishment Address
No. 5, Dapumeiyuanqu 20th Rd., Dalin Township, Chiayi County 62248, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
SIGMA-CARE DEVELOPMENT CO., LTD. (Owner Number: 9046220)
Owner / Operator Contact Address
No. 5, Dapumeiyuanqu 20th Rd., Dalin Township, Chiayi County, TW-CYQ 62248, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hygiene Products; Sigma-Care / B-Life Geriatric Chair; Sigma-Care / B-Life Non-Powered Flotation Mattress; Sigma-Care / B-Life Stretcher Wheeled; Sigma-Care / B-Life Manual Adjustable Hospital Bed; Sigma-Care / B-Life

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2022-11-03
FRJ Chair, Geriatric General Hospital Class 1 880.6140 2015-06-05
IKY Mattress, Flotation Therapy, Non-Powered General Hospital Class 1 880.5150 2022-11-03
FPO Stretcher, Wheeled General Hospital Class 2 880.6910 2014-06-07
FNJ Bed, Manual General Hospital Class 1 880.5120 2001-05-23

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

SIGMA-CARE DEVELOPMENT 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
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-05 Stryker Medical 2
Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

Similar Registrations

Registration Number Establishment Name Location
3010875172 COMMUNITY MEDICAL PRODUCTS LLC Prairie du Sac, WI, US
3043126945 DONGGUAN QIANHE ELECTRONIC TECHNOLOGY CO., LTD. Dongguan Guangdong, CN
3032027168 GUANGDONG ZHONGZE ALUMINUM CO., LTD Foshan Guangdong, CN
3019502344 FOSHAN MAIKANG MEDICAL EQUIPMENT CO., LTD Foshan Guangdong, CN
3004126239 MERCHSOURCE LLC Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003770834. Last updated year: 2026. Please use registration number 3003770834 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.