Identity
- Trade Name
- ANTERIOR SEGMENT ATTACHMENT KIT AA-1 EUDAMEDFDA UDI
- Generic Name
- Retinal optical coherence tomography system FDA UDI
- Device Name
- Optional Accessories for TOPCON 3D Optical Coherent Tomography EUDAMED
- Model / Reference
- AA-1 EUDAMEDANTERIOR SEGMENT ATTACHMENT KIT AA-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04571130282193 EUDAMEDFDA UDI
- Basic UDI-DI
- 4560126260041U5 EUDAMED
- FDA Product Code
- HKI FDA UDIOBO FDA UDI
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
- GMDN Term
- Retinal optical coherence tomography system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI886.1570 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Anterior Segment Attachment Kit Aa-1 by Topcon Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4560126260041U5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (2)
- EUDAMED c68c4b21-d79f-4dce-9f72-aaef1d270b07 61 fields · synced Jul 9, 2026
- FDA UDI 5cabc1a6-3885-48e1-9ebd-010dbb153105 32 fields · synced May 30, 2026