FDA.report

hetaida

Primary DI
06970289035137
Brand
hetaida
Company
Hetaida Technology Co., Ltd
Model
HTD8808C
Device description
Non-Contact Infrared Body Thermometer
Published
2026-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16970289035134PackageGS140In Commercial Distribution
06970289035137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697028903513416970289035134
06970289035137069702890351376970289035137

GMDN Terms

TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts

PhoneEmail
+86076983326886tomchen@hetaida.com.cn

Regulatory Flags

DUNS number
544474402
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06970289030118hetaidaHTD8216C2026-05-24
06970289035120hetaidaHTD8823US2026-05-24
06970289035144hetaidaHTD8208C2026-05-23
06970289035908HomedicsTIE-240B-BABY2025-06-20
06970289035915HomedicsTIE-240B2025-06-20
16970289035837HetaidaHTD8813C2025-05-12
16970289035844HetaidaK5102US2025-05-12
16970289035851HetaidaD6607US2025-05-12
16970289035868HetaidaHTD6101US2025-05-12
16970289035820HetaidaD6606US2025-05-09
16970289035752CARE VISIONHTD6603US2024-11-30
16970289035769CARE VISIOND6606US2024-11-30
16970289035325HetaidaHTD8813C2021-07-27
16970289035332HetaidaHTD8808C2021-07-27
16970289035561HetaidaHTD8813C2022-12-23
16970289035721HetaidaHTD2601US2024-08-15
16970289035738HetaidaHTD2602US2024-08-15
16970289035660OptimalH8228US2024-05-29
16970289035714NAHTD8808C2024-05-23
16970289035653HetaidaD6606US2024-05-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06970289030118hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035120hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035144hetaidaHetaida Technology Co., LtdFLL2026-05-23
06953205995043Infrared ThermometerShenzhen Jiacom Technology Co., LtdFLL2026-03-20
00850022483370Dr. Noze Best ThermometerDr. Noze Best, LLCFLL2026-03-17
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10328785007975BraunKAZ USA, INC.FLL2026-02-03
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00328785012989BRAUNKAZ USA, INC.FLL2026-02-03
10328785014744BRAUNKAZ USA, INC.FLL2026-02-03
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00328785014662BRAUNKAZ USA, INC.FLL2026-01-27
00328785014716BRAUNKAZ USA, INC.FLL2026-01-27
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06971567043066E+RWenzhou Yosun Medical Technology Co., Ltd.FLL2025-12-29
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