Identity
- Trade Name
- Head & Neck Laser Alignment Tool FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway general purposed ultrasound scan. The apparatus can align the position of head and the general purposed ultrasound probe for automatic multiple-angle ultrasound scan. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway general purposed ultrasound scan. The apparatus can align the position of head and the general purposed ultrasound probe for automatic multiple-angle ultrasound scan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719875623004 FDA UDI
- FDA Product Code
- IWE FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5780 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laser patient positioning system
Head & Neck Laser Alignment Tool by Amcad Biomed Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amcad Biomed Corporation
Sources (2)
- FDA UDI 31687248-e5b2-465f-a010-4734cdb0ea45 33 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026