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HANDHELD REF/KERATOMETER HandyRef-K
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30721-0A30,30721-0A40,30721-0B30,30721-0B40,30721-0C30,30721-0C40,30721-0D30,30721-0D40Model ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K
Identity
- Trade Name
- HANDHELD REF/KERATOMETER HandyRef-K EUDAMEDHANDHELD REF / KERATOMETER FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. The keratometer measures the corneal curvature radius (corneal refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power. This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room. FDA UDI
- Model / Reference
- ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K EUDAMED30721-0A30,30721-0A40,30721-0B30,30721-0B40,30721-0C30,30721-0C40,30721-0D30,30721-0D40 EUDAMEDHandyRef-K FDA UDI
- Description
- The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. The keratometer measures the corneal curvature radius (corneal refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power. This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100769 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669202G4 EUDAMED
- FDA Product Code
- HKO FDA UDIHLQ FDA UDI
- EMDN Code
- Q0299,Z12120113 EUDAMED
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1760 FDA UDI886.1350 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
HANDHELD REF/KERATOMETER HandyRef-K 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 | 4987669202G4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (3)
- EUDAMED e4eb92f1-cf98-45a7-ad02-6412347e0687 61 fields · synced Jun 19, 2026
- FDA UDI b9ba98ea-703d-4b07-91bc-aaa0790e8e9b 34 fields · synced May 30, 2026
- EUDAMED e4eb92f1-cf98-45a7-ad02-6412347e0687-1 61 fields · synced Jun 9, 2026