Integra® Miltex®
Integra® Miltex® Magnifying Loupe 3.0X, Black Frame, Extra Long, 18" to 22" Working Distance
13manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Henan (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Yuchang Optical Glasses Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 5 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Chamfond Biotech Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 9 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Zhejiang Fude Medphotonic Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 4 |
Showing 12 of 13. All 13 manufacturers in China registered for Loupe, Binocular, Low Power
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HJH |
| Device type | Loupe, Binocular, Low Power |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5120 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-22 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-5010 | In distribution | |
| 1-5002 | In distribution | |
| 1-5013 | In distribution | |
| 1-5015 | In distribution | |
| 1-5020 | In distribution | |
| 15056 | In distribution | |
| 1-5011 | In distribution | |
| 1-5017 | In distribution | |
| 1-5018 | In distribution | |
| 1-5022 | In distribution | |
| 1-5005 | In distribution | |
| 1-5014 | In distribution | |
| 1-5012 | In distribution | |
| 15050 | In distribution | |
| 1-5008 | In distribution | |
| 1-5007 | In distribution | |
| 15061 | In distribution | |
| 1-5019 | In distribution | |
| 1-5016 | In distribution | |
| 15060 | In distribution | |
| 1-5021 | In distribution | |
| 1-5025 | In distribution | |
| 15057 | In distribution | |
| 1-5006 | In distribution | |
| 1-5003 | In distribution | |
| 1-5004 | In distribution | |
| 15059 | In distribution | |
| 1-5009 | In distribution | |
| 1-5001 | In distribution | |
| 1-5029 | In distribution | |
| 1-5024 | In distribution | |
| 1-5000 | In distribution | |
| 1-5028 | In distribution | |
| 15058 | In distribution | |
| 1-5023 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 645 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 6 |
| VorOtek O Scope | Vorotek | 4 |
| VorOtek L Scope | Vorotek | 4 |
| HRP | Heine Optotechnik Gmbh & Co. KG. | 3 |
| Protective Lenses | Heine Optotechnik Gmbh & Co. KG. | 3 |
| HR | Heine Optotechnik Gmbh & Co. KG. | 3 |
| C 2.3 K | Heine Optotechnik Gmbh & Co. KG. | 2 |
| VorOtek M Scope | Vorotek | 2 |
| C 2.3 | Heine Optotechnik Gmbh & Co. KG. | 2 |
| Eclipse-146 | Quality Aspirators, Inc. | 1 |
| SuperVu XL Advantage 3.5x, at 42cm working distanc | Rudolf Riester Gmbh | 1 |
Showing 12 of 75. All products under Loupe, Binocular, Low Power
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.