Identity
- Trade Name
- Humphrey Field Analyzer 3 (HFA3) FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis of ocular and neurological disorders including glaucoma. FDA UDI
- Model / Reference
- 830 FDA UDI
- Description
- The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis of ocular and neurological disorders including glaucoma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057748085246 FDA UDI
- FDA Product Code
- HPT FDA UDI
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1605 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Perimeter, automatic
Humphrey Field Analyzer 3 (HFA3) by Carl Zeiss Meditec AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Twinfield 3 — OCULUS Optikgeräte GmbH · Class I
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 1cde503d-6f2d-4243-b80a-70f51088676d 33 fields · synced Jun 8, 2026