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Auto Ref/Keratometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref ABXXCL-23-00001Model HRK-9000A, HRK-8100A, HRK-8000A, HRK-7000A, HRK-1, HRK-7000, ERK-9100
Identity
- Trade Name
- Auto Ref/Keratometer HRK-8100A FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- Auto Ref/Keratometer EUDAMEDAuto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the refraction of examinee’s eyes. FDA UDI
- Model / Reference
- HRK-9000A, HRK-8100A, HRK-8000A, HRK-7000A, HRK-1, HRK-7000, ERK-9100 EUDAMEDABXXCL-23-00001 EUDAMEDHRK-8100A FDA UDI
- Description
- Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the refraction of examinee’s eyes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019600923 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196RK001FH EUDAMED
- Direct Marketing DI
- 08800019600923 EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
- GMDN Term
- Automated ophthalmic refractometer 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 38b92e4d-b426-496c-916d-e61e2f2899b4 61 fields · synced Jul 21, 2026
- FDA UDI 38735d96-5f12-4c55-92d1-8d5cce907a30 33 fields · synced May 30, 2026