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AUTO REF/KERATOMETER ARK-1e
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30715-0040Model ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K
Identity
- Trade Name
- AUTO REF/KERATOMETER ARK-1e EUDAMEDAUTO REF/KERATOMETER FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power. FDA UDI
- Model / Reference
- ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K EUDAMED30715-0040 EUDAMEDARK-1s FDA UDI
- Description
- The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100745 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
- Germany 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-1e 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 (2)
- EUDAMED c0b3644a-8cc1-400e-9254-dc718178c296 61 fields · synced Jun 18, 2026
- FDA UDI cf3d6109-e873-429f-ba49-75c29be99cd9 34 fields · synced May 30, 2026