FDA.reportPublic FDA data

seca mBCA 542

Primary DI
04012030022033
Brand
seca mBCA 542
Company
seca GmbH & Co. KG
Model
542
Catalog number
5420009009
Device description
The BIA handle supports physicians in decision-making regarding diagnosis or therapy based on results of bioelectrical impedance measurements. The BIA handle can be combined with optional accessories and devices to enable the measurements of further parameters.
Published
2025-05-01
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
PUHAnalyzer, body composition, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04012030022033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04012030022033040120300220334012030022033

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)5427322info.us@seca.com

Regulatory Flags#

DUNS number
316584937
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04012030022927seca 40640640600000092026-04-22
04012030020053seca 78778778718210092019-08-31
04012030021531seca 62062062034000092025-11-01
04012030022774seca 28628628613000042025-08-08
04012030022682seca 28428428410001042025-08-07
04012030022699seca 28428428413001042025-08-07
04012030022705seca 28428428413101042025-08-07
04012030022637seca 26426426419000042025-06-02
04012030022668seca 27427427419000042025-06-02
04012030022026seca mBCA 54554554500170092025-05-01
04012030022910seca analytics 12512512520000302025-04-30
04012030021678seca analytics 12512512520000202023-10-12
04012030020503seca analytics 12512512520000102020-10-09
04012030020404seca 33333333310210092020-02-28
04012030008587seca 95495495413090072018-08-15
04012030015820seca 28628628615000092018-08-15
04012030021333seca 874 u+874 u+87410096592024-04-01
04012030018760seca 22422422417140042020-08-31
04012030017879seca 49049049000030012020-02-28
04012030019095seca mVSA 53553553512001312020-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
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