Cirrus Hd-Oct
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CIRRUS HD-OCT Model 5000 EUDAMEDCIRRUS HD-OCT FDA UDI
- Generic Name
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
- Device Name
- CIRRUS HD-OCT EUDAMEDThe CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. FDA UDI
- Model / Reference
- 500, 5000, 6000 EUDAMED2660021175359, 2660021185109, 2660021181258, 2660021185110 EUDAMED5000 FDA UDI
- Description
- The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057748087080 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057748_CIR001_6S EUDAMED
- Direct Marketing DI
- 04057748087080 EUDAMED
- 510(k) Number
- K150977 FDA UDI
- FDA Product Code
- OBO FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Ophthalmic spectral-domain optical coherence tomography system
Cirrus Hd-Oct by Carl Zeiss Meditec AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic spectral-domain optical coherence tomography system.
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Cleared under the same submission
K150977 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 1b88319e-b462-47cf-8582-259d555cd0ed 34 fields · synced Jul 25, 2026
- EUDAMED 62c3f175-526f-4e85-afb5-a775927d7dd5-1 61 fields · synced Jul 25, 2026
- EUDAMED 62c3f175-526f-4e85-afb5-a775927d7dd5-2 61 fields · synced Jul 25, 2026