FDA.reportPublic FDA data

Body Composition Analyzer

Primary DI
04904785198449
Brand
Body Composition Analyzer
Company
TANITA CORPORATION
Model
MC-980U plus
Catalog number
MC-980U plus WH
Published
2025-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04904785198449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04904785198449049047851984494904785198449

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Contacts#

Phone, Email table
PhoneEmail
99999999994health@tanita.com

Regulatory Flags#

DUNS number
690539978
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04904785196209Body Composition AnalyzerMC-980U plusMC-980U plus BK2025-01-01
04904785230491Body Composition AnalyzerMC-980U plusMC-980U plus Matte Black2025-10-24
04904785198456Body Composition AnalyzerMC-780U plusMC-780U plus ALL White2025-09-22
04904785043572TANITA Degital Baby ScaleBD-5902019-08-19
14904785043579TANITA Degital Baby ScaleBD-5902019-08-19
04904785043640TANITA Digital Baby Scale15842019-12-24
04904785043657TANITA Digital Baby ScaleBD-5852019-12-24
04904785044968TANITA Body Composition MonitorBC-730BC-730 BK2019-12-24
04904785045002TANITA Digital Baby ScaleBD-5902019-12-24
04904785043633TANITA Digital Baby Scale15832019-12-24
14904785043647TANITA Digital Baby Scale15842019-12-24
14904785043654TANITA Digital Baby ScaleBD-5852019-12-24
04904785043664TANITA Digital Baby ScaleBD-815ML2019-12-24
04904785043671TANITA Digital Baby ScaleBD-815U2019-12-24
14904785044965TANITA Body Composition MonitorBC-730BC-730 BK2019-12-24
04904785044975TANITA Body Composition MonitorBC-730BC-730 WH2019-12-24
14904785045009TANITA Digital Baby ScaleBD-5902019-12-24
04904785060012TANITA Multi- Frequency Body Composition AnalyzerMC-980U plusMC-980U plus CG2016-09-23
04904785196193Body Composition AnalyzerMC-780U plusMC-780U plus BK2024-12-01
04904785172036TANITA Multi-Frequency Body Composition AnalyzerMC-980U plusMC-980U plus RD2021-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B322F0011ES-BC LD TECHNOLOGY, LLCMNW2024-03-05
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