Biolinq Shine Autonomous Time-in-Range Microsensor

Primary DI
00850068110025
Brand
Biolinq Shine Autonomous Time-in-Range Microsensor
Company
Biolinq Incorporated
Model
82000
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SFUGlucose Range Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFUGlucose Range Monitoring SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240080000Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated2025-09-23SFU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068110001PackageGS11In Commercial Distribution
00850068110025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068110001008500681100018500681100010850068110001
00850068110025008500681100258500681100250850068110025

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system sensorA small, electronic device with micro-needle(s) intended to be inserted percutaneously into interstitial tissue to continuously measure and record interstitial fluid glucose concentrations, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is typically a thin, flexible, needle electrode that uses electrochemical means to convert glucose levels into an electrical signal. It typically has an adhesive covering that holds it to the skin surface, and transmits the signal via a cable or transmitter. This is a single-patient device intended be used for a period before being discarded.

Regulatory Flags#

DUNS number
078535881
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false