Identity
- Trade Name
- SPECTRALIS, HRT3, HEP FDA UDI
- Generic Name
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
- Model / Reference
- HEYEX 2 SW V2.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059237000242 FDA UDI
- FDA Product Code
- HPT FDA UDIMYC FDA UDIOBO FDA UDIMXK FDA UDI
- GMDN Term
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1605 FDA UDI886.1570 FDA UDI886.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Ophthalmic examination slit lampOphthalmic spectral-domain optical coherence tomography systemPerimeter, automaticScanning-laser retinal imaging system
Spectralis, Hrt3, Hep by Heidelberg Engineering — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heidelberg Engineering
Sources (1)
- FDA UDI dff9d58c-fe00-4267-b141-e8e25c17aaf3 32 fields · synced May 30, 2026