Encore 26
Inflation Device
16manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | PTM |
| Device type | Syringe, Balloon Inflation, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2020-05-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0067101140 | In distribution | |
| M00566670 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-08-05 | Class II | Under Investigation by firm | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate | 39739 units |
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.