Identity
- Trade Name
- VELARA 200 EUDAMEDCarl Zeiss Meditec FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- VELARA 200 EUDAMED
- Model / Reference
- Velara 200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000428 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000428M6 EUDAMED
- FDA Product Code
- HKI FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Market of Registration
- France 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
Category: Ophthalmic fundus camera
Carl Zeiss Meditec by Luneau Technology Operations — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic fundus camera.
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- VISUCAM 224 — Carl Zeiss Meditec AG · Class II
- NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI dca0b905-b509-4446-980d-e43d57cd82ed 32 fields · synced Jul 10, 2026
- EUDAMED a75fddd0-eb60-45c6-a426-7fe18330597a 61 fields · synced Jul 10, 2026