microdot® Pro Glucometer

FDA UDI

Class I (US FDA UDI)

by Cambridge Sensors USA, LLC.

Identity

Trade Name: microdot® Pro Glucometer FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: microdot® Pro Glucometer FDA UDI
Model / Reference: 400-01 FDA UDI
Description: microdot® Pro Glucometer FDA UDI

Identifiers

Primary DI / UDI-DI: 00847713000787 FDA UDI
510(k) Number: K161299 FDA UDI
FDA Product Code: JJX FDA UDI
LFR FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1345 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

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

Category: Glucose monitoring system IVD, home-use

microdot® Pro Glucometer by Cambridge Sensors USA, LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161299 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: Cambridge Sensors USA, LLC.

Sources (1)

FDA UDI ce77d5ae-864a-4e62-8484-e0d377548556 34 fields · synced Jun 6, 2026