| Primary Device ID | 08800019600923 |
| NIH Device Record Key | 38735d96-5f12-4c55-92d1-8d5cce907a30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auto Ref/Keratometer HRK-8100A |
| Version Model Number | HRK-8100A |
| Company DUNS | 688154202 |
| Company Name | Huvitz Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800019600923 [Primary] |
| HKO | Refractometer, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-01 |
| Device Publish Date | 2023-08-24 |
| 08800019600978 - Instrument Table CIT-4100 | 2024-07-02 Instrument Table CIT-4100 |
| 08800019600985 - Instrument Table CIT-4200 | 2024-07-02 Instrument Table CIT-4200 |
| 08800019600893 - Lilivis Scan LS-100 | 2024-06-04 Lilivis Scan LS-100 (Intraoral Scanner) |
| 08800019600909 - Lilivis CAD L-CAD | 2024-06-04 Lilivis CAD L-CAD (Chairside CAD Software) |
| 08800019600787 - Optical Biometer HBM-1 | 2023-10-26 The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature |
| 08800019600916 - Digital Refractor HDR-7100P | 2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p |
| 08800019600923 - Auto Ref/Keratometer HRK-8100A | 2023-09-01Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the refraction of examinee’s eyes. |
| 08800019600923 - Auto Ref/Keratometer HRK-8100A | 2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref |
| 08800019600411 - Applanation Tonometer HT-5000 | 2023-06-20 Applanation Tonometer HT-5000 |