Identity
- Trade Name
- HENSON 9000 EUDAMEDTOPCON FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- HENSON 9000 EUDAMEDAutomated Perimeter FDA UDI
- Model / Reference
- HENSON 9000 EUDAMEDFDA UDIHENSON9000 EUDAMED
- Description
- Automated Perimeter FDA UDI
Identifiers
- Catalog Number
- HENSON9000 FDA UDI
- Primary DI / UDI-DI
- 08034028770418 EUDAMEDFDA UDI
- Basic UDI-DI
- 803402877PERIMETER1DM EUDAMED
- FDA Product Code
- HPT FDA UDI
- EMDN Code
- Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1605 FDA UDI
- Market of Registration
- Sweden 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Perimeter, automatic
Henson 9000 by Visia Imaging Srl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803402877PERIMETER1DM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Visia imaging SRL
- EUDAMED SRN
- IT-MF-000015628
Sources (2)
- EUDAMED c0f159a0-69d4-4497-be5d-1174c8eedda6 61 fields · synced Jun 18, 2026
- FDA UDI e8952227-77d3-4d45-a648-579d79ccec8b 34 fields · synced May 29, 2026