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Auto Ref/Keratometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref A9ARAA-17-00001Model HRK-9000A, HRK-8100A, HRK-8000A, HRK-7000A, HRK-1, HRK-7000, ERK-9100
Identity
- Trade Name
- Ref-Keratometer HRK-1 FDA UDI
- Generic Name
- Ophthalmic refractometer, manual FDA UDI
- Device Name
- Auto Ref/Keratometer EUDAMEDThe Ref/Keratometer is intended to be used to measure the refractive power of the eye FDA UDI
- Model / Reference
- HRK-9000A, HRK-8100A, HRK-8000A, HRK-7000A, HRK-1, HRK-7000, ERK-9100 EUDAMEDA9ARAA-17-00001 EUDAMEDHRK-1 FDA UDI
- Description
- The Ref/Keratometer is intended to be used to measure the refractive power of the eye FDA UDI
Identifiers
- Catalog Number
- HRK-1 FDA UDI
- Primary DI / UDI-DI
- 08800019600480 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196RK001FH EUDAMED
- Direct Marketing DI
- 08800019600480 EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
- GMDN Term
- Ophthalmic refractometer, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1760 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
No
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
Yes
FDA UDI
Auto Ref/Keratometer by Huvitz Co., Ltd. — Class I — 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 | 88000196RK001FH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f402216b-d420-4bf2-8f57-c0b835f32291 61 fields · synced Jul 23, 2026
- FDA UDI 3001b287-1499-4137-b108-52bd08321897 35 fields · synced May 26, 2026