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UTAS Pattern/Multifocal System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 00857901006583
Identity
- Trade Name
- UTAS Pattern/Multifocal System EUDAMEDUTAS FDA UDI
- Generic Name
- Electroretinograph FDA UDI
- Device Name
- UTAS Pattern/Multifocal System EUDAMED
- Model / Reference
- 00857901006583 EUDAMEDUTAS System Type-50L Pattern/Multifocal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857901006583 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857901006UTAS79 EUDAMED
- FDA Product Code
- GWE FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Electroretinograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
UTAS Pattern/Multifocal System by LKC Technologies — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0857901006UTAS79 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- LKC Technologies
- EUDAMED SRN
- US-MF-000030631
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7543cd41-da0b-4e29-92d8-1164f6136fc5 61 fields · synced Jul 17, 2026
- FDA UDI ea207a6a-036a-4bd5-8a43-d87c00ac5571 33 fields · synced May 29, 2026