← Back to catalogue
AUTO REFRACTOMETER AR-1a
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30612-0040Model AR-1,AR-1a,AR-1s,HandyRef,AR-F
Identity
- Trade Name
- AUTO REFRACTOMETER AR-1a EUDAMEDAUTO REFRACTOMETER FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. FDA UDI
- Model / Reference
- AR-1,AR-1a,AR-1s,HandyRef,AR-F EUDAMED30612-0040 EUDAMEDAR-1a FDA UDI
- Description
- The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100691 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669201G2 EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Market of Registration
- Norway 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AUTO REFRACTOMETER AR-1a by Nidek Co., Ltd. — Class IIa — 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 | 4987669201G2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (2)
- EUDAMED 03118ea3-5d9b-46a4-aee3-c5fbf4c46fbe 61 fields · synced Jul 22, 2026
- FDA UDI be6eaa4c-fa35-46b8-9644-327221fa437b 34 fields · synced May 30, 2026