Seirin Pyonex Needles
Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Singles continue SEIRIN's tradition of gentle, painless and stress free press needles. The patented…
Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Singles continue SEIRIN’s tradition of gentle, painless and stress free press needles. The patented plastic case and sheath allow the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic latex-free adhesive allows the skin to breathe during treatment. With SEIRIN’s consistently smooth insertion, the result is a pleasant and painless experience for your patient.
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (3), Tianjin (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Hengxiang IMP. & EXP. Co., Ltd. | Suzhou | Jiangsu | Exporter | 35 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou | Jiangsu | Remanufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 13 |
| Hangzhou Goals Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Guangzhou Ahead Intelligent Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| Tianjin Huahong Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Wuxi Jiajian Medical Instrument Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Needle, Acupuncture, Single Use
Record
| Listed by | Seirin Corporation, Japan |
|---|---|
| FDA product code | MQX |
| Device type | Needle, Acupuncture, Single Use |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5580 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-02-11 |
| Record revised | 2026-02-12 (version 6) |
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, manufacturing date |
| Packaging | Box of 10 |
| Sizes | Outer diameter 0.11 to 0.2 mm; length 0.3 to 1.7 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Pyonex 0.20×1.7mm | Outer Diameter 0.2 mm | 100 | In distribution |
| PYONEX 0.3mm | Outer Diameter 0.11 mm | 100 | In distribution |
| PYONEX 1.7mm | Outer Diameter 0.2 mm | 100 | In distribution |
| PYONEX 1.2mm | Length 1.2 mm | 100 | In distribution |
| Pyonex Green 0.17×0.9mm | Outer Diameter 0.17 mm | 100 | In distribution |
| PYONEX 0.9mm | Outer Diameter 0.17 mm | 100 | In distribution |
| Pyonex Orange 0.11×0.3mm | Outer Diameter 0.11 mm | 100 | In distribution |
| Pyonex Pink 0.20×1.5mm | Outer Diameter 0.2 mm | 100 | In distribution |
| PYONEX 0.6mm | Outer Diameter 0.15 mm | 100 | In distribution |
| Pyonex Yellow 0.15×0.6mm | Outer Diameter 0.15 mm | 100 | In distribution |
| Pyonex Blue 0.20×1.2mm | Length 1.2 mm | 100 | In distribution |
| PYONEX 1.5mm | Outer Diameter 0.2 mm | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Acupuncture Needles FOR Single USE | Changchun AIK Medical Devices Co., Ltd. | 397 |
| Seirin Acupuncture Needle | Seirin Corporation | 218 |
| Tewa | Asia-MED Gmbh | 186 |
| Tewa | asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG | 184 |
| Eacu, Eaku, Zagu, Jocu | Maanshan Bond Medical Instruments Co., Ltd. | 176 |
| AcuZone | Wujiang City ShenLing Medical Device Co., Ltd. | 158 |
| Lekon | C.A.I. Industries Corp. | 129 |
| TCMzoneHuaTuo | Tcmzone, LLC | 129 |
| Carbo | Wujiang City Cloud & Dragon Medical Device Co., Ltd. | 115 |
| Carbo | Wujiang City ShenLing Medical Device Co., Ltd. | 114 |
| ACE | Wuxi Jiajian Medical Instrument Co., Ltd. | 113 |
| Silverstar | Health Body World Supply Inc. | 101 |
Showing 12 of 184. All products under Needle, Acupuncture, Single Use
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.