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Auto Ref/Keratometer Ark-F
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30741-0A40,30741-0B40,30741-0C40,30741-0D40,30741-0E40,30741-0F40Model ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K
Identity
- Trade Name
- AUTO REF/KERATOMETER ARK-F EUDAMEDAUTO REF/KERATOMETER FDA UDI
- Generic Name
- Bench-top keratometer FDA UDI
- Device Name
- The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors and corneal curvature radius of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation. FDA UDI
- Model / Reference
- ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K EUDAMED30741-0A40,30741-0B40,30741-0C40,30741-0D40,30741-0E40,30741-0F40 EUDAMEDARK-F FDA UDI
- Description
- The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors and corneal curvature radius of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101476 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669202G4 EUDAMED
- FDA Product Code
- HLQ FDA UDIHKO FDA UDI
- EMDN Code
- Q0299,Z12120113 EUDAMED
- GMDN Term
- Bench-top keratometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1350 FDA UDI886.1760 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
Auto Ref/Keratometer Ark-F 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 157c0c06-0c3e-46a2-9f28-b2714c1150fa 61 fields · synced Jul 21, 2026
- FDA UDI 0a10cbd8-a5de-4a6b-804f-44b63d52287a 34 fields · synced May 30, 2026
- EUDAMED 157c0c06-0c3e-46a2-9f28-b2714c1150fa-1 61 fields · synced Jun 10, 2026