| Primary Device ID | 08800019600916 |
| NIH Device Record Key | d9e2c61a-190f-4ff3-868a-4e5b8c6a69de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digital Refractor HDR-7100P |
| Version Model Number | HDR-7100P |
| 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 | 08800019600916 [Primary] |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter |
| 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 |
| 00880019600961 - Lilivis SCAN OPTOMO | 2024-12-04 Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical chara |
| 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 | 2023-09-01The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities. Also the Digital Refractor is used for detecting and measuring any anomalies in binocular vision such as muscle balance, binocular balance, aniseikonia, fusion, and stereopsis. |
| 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 | 2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref |