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Clarus
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2660021166134, 2660021173632, 2660021184538Model 500, 700
Identity
- Trade Name
- CLARUS 500 EUDAMEDCLARUS FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- CLARUS EUDAMEDThe CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. FDA UDI
- Model / Reference
- 500, 700 EUDAMED2660021166134, 2660021173632, 2660021184538 EUDAMED500 FDA UDI
- Description
- The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057748096037 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057748_CLA001_26 EUDAMED
- Direct Marketing DI
- 04057748096037 EUDAMED
- 510(k) Number
- K181444 FDA UDI
- FDA Product Code
- QER 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
- 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fundus camera
Clarus by Carl Zeiss Meditec AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic fundus camera.
- RetCam Portable — Natus Medical, Inc. · Class II
- 3nethra — FORUS HEALTH PRIVATE LIMITED · Class II
- Welch Allyn — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- iCam — OPTOVUE, INC. · Class II
- RetCam 3 — Natus Medical, Inc. · Class II
- Volk Pictor VP1ANT — VOLK OPTICAL INC. · Class II
- NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · Class II
- RETINAL CAMERA TRC-50DX — Topcon Corp. · Class II
Cleared under the same submission
K181444 also covers:
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
- Carl Zeiss Meditec AG
Sources (3)
- FDA UDI f488dec3-78a0-4295-86fc-4ada98cb84e2 34 fields · synced Jun 19, 2026
- EUDAMED ee2b3c57-1c6d-400c-a1a8-467dc8e30a69-1 61 fields · synced Jun 14, 2026
- EUDAMED ee2b3c57-1c6d-400c-a1a8-467dc8e30a69-2 61 fields · synced Jun 14, 2026