AccuVein
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10manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BLZ Technology (Wuhan) Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 3 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Beijing Konted Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 4 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Medcaptain Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
| Shenzhen Yuanhua Medical Equipment Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | AccuVein Inc., United States |
|---|---|
| FDA product code | KZA |
| Device type | Device, Vein Location, Liquid Crystal |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6970 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-25 |
| Record revised | 2024-12-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HF510 | In distribution | |
| HF550 | In distribution | |
| HF580 | In distribution | |
| AV500 | In distribution | |
| HF570 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vein Illuminator | Medcaptain Medical Technology Co., Ltd. | 2 |
| AHT Inc | AHT Inc | 1 |
| VeinViewer 3.0 Flex | Christie Medical Holdings, Inc. | 1 |
| Veinsite | Spirometrics, Inc. | 1 |
| Veincas | Shenzhen Vivolight Medical Device&Technology Co., Ltd. | 1 |
| Meerkat Vein Finder model | Opcom Inc. | 1 |
| VeinViewer 4.0 Vision2 | Christie Medical Holdings, Inc. | 1 |
| NextVein | Nextvein LLC | 1 |
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.