Identity
- Trade Name
- Ref/Keratometers HRK-7000 FDA UDI
- Generic Name
- Ophthalmic refractometer, manual FDA UDI
- Device Name
- The Ref/Keratometer is intended to be used to measure the refractive power of the eye FDA UDI
- Model / Reference
- HRK-7000 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-7000 FDA UDI
- Primary DI / UDI-DI
- 08800019600138 FDA UDI
- FDA Product Code
- HKO FDA UDI
- GMDN Term
- Ophthalmic refractometer, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Ophthalmic refractometer, manual
Ref/Keratometers HRK-7000 by Huvitz Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic refractometer, manual.
- Park 1 — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- Gilras — U.S. OPHTHALMIC, L.L.C. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
Sources (1)
- FDA UDI 4b75d96c-c0de-4e2e-8fa9-de7c2625f391 35 fields · synced Jun 1, 2026