FDA.reportPublic FDA data

Bioland

Primary DI
06939184620121
Brand
Bioland
Company
Bioland Technology Ltd.
Model
T103
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FLLContinuous Measurement Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201879000Digital Thermometer Model T103, T104Bioland Technology, Ltd.2021-03-31FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06939184620121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06939184620121069391846201216939184620121

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Regulatory Flags#

DUNS number
545852548
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939184612621BiolandE1262026-04-14
06939184620039BiolandE2012026-04-14
06939184620138BiolandT1042026-04-14
06934440101116WellueBioland2021-01-20
06939184600192telli healthbioland2021-03-06
06939184600178biolandBioland2021-01-20
06939184642529BiolandG-425-22024-03-26
16939184642526BiolandG-425-22024-03-26
06939184601359GlucoracyG-425-2S2024-03-25
16939184601356GlucoracyG-425-2S2024-03-25
06939184610726INSMART20052023-11-01
16939184610723INSMART20052023-11-01
06939184600949GlucoracyLEVEL 22023-10-07
06939184630892GlucoracyG-427B2023-10-07
16939184600946GlucoracyLEVEL 22023-10-07
16939184630899GlucoracyG-427B2023-10-07
06939184630885GlucoracyG-425-22023-09-19
16939184630882GlucoracyG-425-22023-09-19
06939184600352ELERAG-427BS2023-08-15
06939184600482GlucoracyG-425-2S2023-08-15

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22