Identity
- Trade Name
- ANTERIOR ATTACHMENT HA-2 FDA UDI
- Generic Name
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
- Model / Reference
- HA-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04571130282186 FDA UDI
- FDA Product Code
- HKI FDA UDIOBO FDA UDI
- GMDN Term
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI886.1570 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic spectral-domain optical coherence tomography system
Anterior Attachment Ha-2 by Topcon Corp. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Topcon Corp.
Sources (1)
- FDA UDI 305f2d2b-8b8d-45cc-940a-0d1539d0fcf1 32 fields · synced May 31, 2026