Identity
- Trade Name
- A.M.I. HAL-II Adaptor USA FDA UDI
- Generic Name
- Electrosurgical cable adaptor FDA UDI
- Model / Reference
- AHA 003 FDA UDI
Identifiers
- Catalog Number
- AHA 003 FDA UDI
- Primary DI / UDI-DI
- EAMIAHA0030 FDA UDI
- 510(k) Number
- K061831 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Electrosurgical cable adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
A.M.I. HAL-II Adaptor USA by AMI Agency for Medical Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI cc17dfd2-1a9d-4ac7-89bc-4ba3d33f8b87 35 fields · synced Jun 8, 2026