Identity
- Trade Name
- HUVITZ EUDAMEDAutomated Perimetery HVF-100 FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- Automatic Perimeter EUDAMEDAutomated Perimetery HVF-100 FDA UDI
- Model / Reference
- HVF-100 EUDAMEDFDA UDICTXXCL-22-00001 EUDAMED
- Description
- Automated Perimetery HVF-100 FDA UDI
Identifiers
- Catalog Number
- HVF-100 FDA UDI
- Primary DI / UDI-DI
- 08800019600824 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196VF001FS EUDAMED
- Direct Marketing DI
- 08800019600824 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
- Italy 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Perimeter, automatic
Huvitz by Huvitz Co., Ltd. — 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 | 88000196VF001FS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f8e56576-9995-41bb-acac-bb4c2c2b84f7 61 fields · synced Jul 22, 2026
- FDA UDI b9be882b-4dbe-4925-a85a-d0ec51c5c1b5 35 fields · synced May 29, 2026