← Back to catalogue

AlcoMate

FDA UDI

Class II (US FDA UDI)

by Ak Globaltech Corp

Identity

Trade Name
AlcoMate FDA UDI
Generic Name
Alcohol breath analyser FDA UDI
Device Name
The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first. FDA UDI
Model / Reference
SM7000 FDA UDI
Description
The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first. FDA UDI

Identifiers

Catalog Number
AKG SM7000 FDA UDI
Primary DI / UDI-DI
00853464001119 FDA UDI
FDA Product Code
OIC FDA UDI
DJZ FDA UDI
GMDN Term
Alcohol breath analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3040 FDA UDI
862.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Alcohol breath analyser

AlcoMate by Ak Globaltech Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alcohol breath analyser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ak Globaltech Corp

Sources (1)

  • FDA UDI e8bf956a-be85-4ea7-bf4f-6f4f5774b535 36 fields · synced May 30, 2026