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OPTICAL BIOMETER AL-Scan
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref B01E012Model AL-Scan
Identity
- Trade Name
- OPTICAL BIOMETER AL-Scan EUDAMEDOPTICAL BIOMETER FDA UDI
- Generic Name
- Optical pachymeter FDA UDI
- Device Name
- The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length. FDA UDI
- Model / Reference
- AL-Scan EUDAMEDFDA UDIB01E012 EUDAMED
- Description
- The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100547 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669210G3 EUDAMED
- FDA Product Code
- HJO FDA UDIIYO FDA UDI
- EMDN Code
- Z11040101,Z12120108,Z12120113,Z12120116 EUDAMED
- GMDN Term
- Optical pachymeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI892.1560 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
OPTICAL BIOMETER AL-Scan by Nidek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133132 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4987669210G3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (3)
- EUDAMED 61cf5625-dc52-4a4b-b33a-ac5eec2e4fe1 61 fields · synced Jul 14, 2026
- FDA UDI 2376551d-fd58-429f-a93c-0f3d5806dc81 34 fields · synced May 30, 2026
- FDA 510(k) K133132 1 fields · synced May 18, 2026