Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009507357

FEI Number

3009507357

Entity Name

WHOLECARE BIOMEDICAL CORPORATION

City/State/Country

Taipei City, TW

Establishment Address

8F, No. 443, Ruiguang Rd, Neihu Dist., Taipei City 114, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Wholecare Biomedical Corporation (Owner Number: 10039146)

Owner / Operator Contact Address

8F, No. 443, Ruiguang Rd, Neihu Dist., Taipei City, TW-TPE 114, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MedGem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2021-08-17
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2011-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Wholecare Biomedical Corporation

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
K802417	Siemens Elema AB	AB O2 CONSUMPTION CALCULATOR 980	1980-10-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009507357. Last updated year: 2026. Please use registration number 3009507357 when referencing this establishment in official correspondence.