Identity
- Trade Name
- Auto Ref/Keratometer EUDAMEDFDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- Auto Ref/Keratometer EUDAMEDThis instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. KR-9000 Auto ref/keratometer Has the functions of both refractometer and keratometer Adopts the latest ARM processor and image processing technology—fast system and more clear images Mature technique from Japan. Humanized auto mist test process: will reduce the errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD screen provides more comfortable interface Supports data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure give the customer sense of beauty and comfortable operation. FDA UDI
- Model / Reference
- KR-9000 EUDAMEDFDA UDI
- Description
- This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. KR-9000 Auto ref/keratometer Has the functions of both refractometer and keratometer Adopts the latest ARM processor and image processing technology—fast system and more clear images Mature technique from Japan. Humanized auto mist test process: will reduce the errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD screen provides more comfortable interface Supports data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure give the customer sense of beauty and comfortable operation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971821402004 EUDAMEDFDA UDI
- Basic UDI-DI
- 69718214002V8 EUDAMED
- Direct Marketing DI
- 06971821402004 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
- 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
No
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 by Ningbo Ming Sing Optical R&D 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 | 69718214002V8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Ming Sing Optical R&D Co., Ltd.
- EUDAMED SRN
- CN-MF-000012092
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED fd6f0389-2749-4643-a75e-c78610139036 61 fields · synced Jul 8, 2026
- FDA UDI 685f477c-bfe7-4751-a6e9-b491203b1bfe 34 fields · synced May 30, 2026