Identity
- Trade Name
- Smartfield EUDAMEDFDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- Smartfield EUDAMEDFDA UDI
- Model / Reference
- 14000 EUDAMEDFDA UDI
- Description
- Smartfield FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584019363 EUDAMEDFDA UDI
- Basic UDI-DI
- 40495842BC EUDAMED
- FDA Product Code
- HPT FDA UDIHOO 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
- 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
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
Smartfield by OCULUS Optikgeräte GmbH — 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 | 40495842BC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED de8f71dc-8062-4416-bdb3-5fb2908c5024 61 fields · synced Jul 24, 2026
- FDA UDI e9245ad1-93d6-4161-b1a7-698d25f62f61 34 fields · synced May 30, 2026