Thinklabs

FDA UDI

Class II (US FDA UDI)

by Thinklabs Medical Llc

Identity

Trade Name: Thinklabs FDA UDI
Generic Name: Electronic acoustic stethoscope FDA UDI
Device Name: The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any use except as indicated. The Thinklabs One is designed to be used by medical and allied professionals and trainees enrolled in professional training programs. Operation of the device requires no special training beyond the user following the instructions for use on Thinklabs website. Accurate patient diagnosis with a stethoscope requires the operator to have auscultation skills. FDA UDI
Model / Reference: One FDA UDI
Description: The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any use except as indicated. The Thinklabs One is designed to be used by medical and allied professionals and trainees enrolled in professional training programs. Operation of the device requires no special training beyond the user following the instructions for use on Thinklabs website. Accurate patient diagnosis with a stethoscope requires the operator to have auscultation skills. FDA UDI

Identifiers

Primary DI / UDI-DI: 00899529001106 FDA UDI
510(k) Number: K032230 FDA UDI
FDA Product Code: DQD FDA UDI
GMDN Term: Electronic acoustic stethoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1875 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 0.075 Pound FDA UDI
Height — 1.2 Inch FDA UDI
Outer Diameter — 1.75 Inch FDA UDI

Category: Electronic acoustic stethoscope

Thinklabs by Thinklabs Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Thinklabs Medical Llc

Sources (1)

FDA UDI 22da8d0c-8c99-489b-bb9d-a9d3a762e148 38 fields · synced May 30, 2026