Lumiflex
Lumiflex Balloon Inflator
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (7), Guangdong (4), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Brun Medical Co., Ltd. | Zhuzhou | Hunan | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Syringe, Balloon Inflation, Exempt
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | PTM |
| Device type | Syringe, Balloon Inflation, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Premarket notification | Exempt |
| Record published | 2025-08-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00733223 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| basixCOMPAK™ | Merit Medical Systems, Inc. | 58 |
| basixTOUCH™ | Merit Medical Systems, Inc. | 21 |
| Angioway | Lepu Medical Technology (Beijing) Co., Ltd. | 14 |
| Balloon inflation device | Tianck Medical Co., Ltd. | 9 |
| basixALPHA™ | Merit Medical Systems, Inc. | 8 |
| Genoss Inflator B30 | Genoss Co., Ltd. | 5 |
| basixTau™ | Merit Medical Systems, Inc. | 5 |
| Genoss Inflator B40 | Genoss Co., Ltd. | 5 |
| Namic | Medline Industries, Inc. | 4 |
| GM-30 Accessory Kit | Nipro Vascular Innovations Americas, Inc. | 4 |
| BlueFIRE™ | Merit Medical Systems, Inc. | 4 |
| basixSKY™ | Merit Medical Systems, Inc. | 4 |
Showing 12 of 25. All products under Syringe, Balloon Inflation, Exempt
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.