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Humphrey Field Analyzer 3 (HFA3)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 2660021171818, 2660021185054Model 830, 840, 850, 860
Identity
- Trade Name
- Humphrey Field Analyzer 3 Model 840 EUDAMEDHumphrey Field Analyzer 3 (HFA3) FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- Humphrey Field Analyzer 3 EUDAMEDThe 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, 840, 850, 860 EUDAMED2660021171818, 2660021185054 EUDAMED840 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
- 04057748085253 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057748_HFA001_2D EUDAMED
- Direct Marketing DI
- 04057748085253 EUDAMED
- FDA Product Code
- HPT FDA UDI
- EMDN Code
- Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1605 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- VisionOne — PeriVision SA · Class I
- Twinfield 3 — OCULUS Optikgeräte GmbH · Class I
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
- Carl Zeiss Meditec AG
Sources (3)
- FDA UDI fe09d954-4269-44c2-8446-c4157a423f8c 33 fields · synced Jul 10, 2026
- EUDAMED e6f09426-4c37-44d1-be49-fec603731c00-1 61 fields · synced Jul 10, 2026
- EUDAMED e6f09426-4c37-44d1-be49-fec603731c00-2 61 fields · synced Jul 10, 2026