FDA.reportPublic FDA data

ANOVATOR

Primary DI
16977035520036
Brand
ANOVATOR
Company
Wuhan Zhaike Network Technology Company, Limited
Model
S2
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
16977035520036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697703552003616977035520036

GMDN Terms#

Term, Definition table
TermDefinition
Tapentadol IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tapentadol in a clinical specimen, using an enzyme immunoassay (EIA) method.

Regulatory Flags#

DUNS number
544378637
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16977035520005ANOVATORS92026-03-27
16977035520012ANOVATORS02026-03-27
16977035520029ANOVATORS12026-03-27
16977035520043ANOVATORS32026-03-27
16977035520050ANOVATORS42026-03-27
16977035520067ANOVATORS52026-03-27
16977035520074ANOVATORS62026-03-27
16977035520081ANOVATORS72026-03-27
16977035520098ANOVATORS82026-03-27
16977035520104ANOVATORM02026-03-27
16977035520111ANOVATORM12026-03-27
16977035520128ANOVATORM22026-03-27
16977035520135ANOVATORM32026-03-27
16977035520142ANOVATORM42026-03-27
16977035520159ANOVATORM52026-03-27
16977035520166ANOVATORM62026-03-27
16977035520173ANOVATORM72026-03-27
16977035520180ANOVATORM82026-03-27
16977035520197ANOVATORM92026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719846013230CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
00810140063007RENPHOJoicom CorporationPUH2026-04-20
00810140062994RENPHOJoicom CorporationPUH2026-04-08
16977035520005ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520012ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520029ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520043ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520050ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520067ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520074ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520081ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520098ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520104ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520111ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520128ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520135ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520142ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520159ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520166ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520173ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520180ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520197ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
00694501143849Health O MeterStar Elite IncPUH2026-03-25
00694501143863Health O MeterStar Elite IncPUH2026-03-25
00810140062901RENPHOJoicom CorporationPUH2026-01-04
00810140062840RENPHOJoicom CorporationPUH2025-11-25
00810140062819RENPHOJoicom CorporationPUH2025-10-24
08809209592253InBodyInBody Co., Ltd.PUH2025-10-03
04719846016507CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-12