Identity
- Trade Name
- i.Terminal 2 EUDAMEDFDA UDI
- Generic Name
- Vision corrective spectacles centration image analysis software FDA UDI
- Device Name
- i.Terminal 2 EUDAMEDN/A FDA UDI
- Model / Reference
- 000000-2408-310 EUDAMEDFDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- 000000-2408-310 FDA UDI
- Primary DI / UDI-DI
- 04250668606717 EUDAMEDFDA UDI
- Basic UDI-DI
- 42506686-S01-IT2-XE EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Vision corrective spectacles centration image analysis software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
i.Terminal 2 by Carl Zeiss Vision Gmbh — Class I — 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 | 42506686-S01-IT2-XE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
- EUDAMED SRN
- DE-MF-000006173
Sources (2)
- EUDAMED d4565ada-4509-47be-b9cb-7d27456ccf9c 61 fields · synced May 31, 2026
- FDA UDI 99e280ad-a186-4682-9570-6a1d12e98186 35 fields · synced May 29, 2026