Ocu-Film® +”
Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
5manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Reichert Inc., United States |
|---|---|
| FDA product code | HKY |
| Device type | Tonometer, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1930 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070534 |
| Record published | 2025-08-15 |
| Record revised | 2025-10-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 230653 | In distribution | |
| 230651 | In distribution | |
| 230652 | Withdrawn | |
| 230651 | Withdrawn | |
| 230653 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tonometer AT 900 | Haag-Streit AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 5 |
| AccuTip Cover | Accutome, Inc. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 4 |
| Applanation Tonometer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 3 |
| Icare ic200 | Icare Finland Oy | 3 |
| Marco | Takagi Seiko Co., Ltd. | 2 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 2 |
| iCare PATIENT2 | Icare Finland Oy | 2 |
| Tonometer AT 870 | Haag-Streit AG | 2 |
| Takagi | Takagi Seiko Co., Ltd. | 2 |
Showing 12 of 71. All products under Tonometer, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233516 | 2024-05-01 |
| K070534 | 2007-03-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.