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Sign in to claim this brandAK GLOBALTECH CORP
US
Last updated September 17, 2026
What AK GLOBALTECH CORP makes
AK GlobalTech Corp manufactures alcohol breath analysers designed for measuring blood alcohol concentration (BAC) through breath samples. These devices are primarily used in workplace safety, law enforcement, and personal monitoring applications to assess intoxication levels.
The company’s breath analysers are classified as Class II medical devices under US regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use within the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AK GlobalTech Corp manufacture?
AK GlobalTech Corp specialises in alcohol breath analysers, which measure blood alcohol concentration (BAC) by analysing breath samples. These devices are primarily used in workplace safety programs, law enforcement settings, and personal monitoring to assess intoxication levels.
Where is AK GlobalTech Corp based?
AK GlobalTech Corp is based in the United States. The company’s devices are designed and intended for use within the US market.
How are AK GlobalTech Corp’s devices classified under US regulations?
AK GlobalTech Corp’s alcohol breath analysers fall under the classification of Class II medical devices in the United States. This classification is determined based on their intended use and risk level, requiring compliance with specific regulatory controls to ensure safety and performance.
Are AK GlobalTech Corp’s devices listed in any regulatory registries?
Yes, AK GlobalTech Corp’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorised for use in the US, ensuring transparency and traceability.
What are the primary applications for AK GlobalTech Corp’s alcohol breath analysers?
AK GlobalTech Corp’s alcohol breath analysers are primarily used in workplace safety programs to monitor employee sobriety, by law enforcement for field sobriety testing, and for personal use to track blood alcohol levels. Their design supports reliable BAC measurement through breath samples.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 21 Grand Ave Ste 102, Palisades Park, NJ, 07650
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3004077604
- DUNS Number
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Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AlcoMate | INDMP1000 | FDA UDI | Class II | Active |
| AlcoMate | SM3100 | FDA UDI | Class II | Active |
| AlcoMate | STDMP | FDA UDI | Class II | Active |
| AlcoMate | INDMP | FDA UDI | Class II | Active |
| AlcoMate | STDMP100 | FDA UDI | Class II | Active |
| AlcoMate | Premium AL7000 | FDA UDI | Class II | Active |
| AlcoMate | STDMP500 | FDA UDI | Class II | Active |
| AlcoMate Core | AL6000-L | FDA UDI | Class II | Active |
| AlcoMate | AlcoMate Revo TS200 | FDA UDI | Class II | Active |
| AlcoMate | TS600 | FDA UDI | Class II | Active |
| AlcoMate | STDMP1000 | FDA UDI | Class II | Active |
| AlcoMate | SM6000 | FDA UDI | Class II | Active |
| AlcoMate | SM200 | FDA UDI | Class II | Active |
| AlcoMate | SM7000 | FDA UDI | Class II | Active |
| AlcoMate | AL4000 | FDA UDI | Class II | Active |
| AlcoMate | Prestige AL6000 | FDA UDI | Class II | Active |
| AlcoMate | STDMP20 | FDA UDI | Class II | Active |
| AlcoMate | SM3500FC | FDA UDI | Class II | Active |
| AlcoMate | SM600 | FDA UDI | Class II | Active |
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