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SEIRIN Pyonex Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PYONEX 1.2mmRef PYONEX 0.9mmRef PYONEX 0.6mmRef Pyonex Blue 0.20x1.2mmRef Pyonex Green 0.17x0.9mmRef Pyonex Yellow 0.15x0.6mm
Identity
- Trade Name
- SEIRIN Pyonex Needles EUDAMEDSEIRIN PYONEX FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- SEIRIN Pyonex Needles EUDAMEDDesigned 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. FDA UDI
- Model / Reference
- PYONEX 1.2mm EUDAMEDPYONEX 0.9mm EUDAMEDPYONEX 0.6mm EUDAMEDPyonex Blue 0.20x1.2mm EUDAMEDFDA UDIPyonex Green 0.17x0.9mm EUDAMEDFDA UDIPyonex Yellow 0.15x0.6mm EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248420048 EUDAMEDFDA UDI04547248420031 EUDAMEDFDA UDI04547248420024 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547248SPN001X6 EUDAMEDB-04547248420048 EUDAMEDB-04547248420031 EUDAMEDB-04547248420024 EUDAMED
- Unit of Use DI
- 24547248420042 EUDAMED24547248420035 EUDAMED24547248420028 EUDAMED
- FDA Product Code
- MQX FDA UDI
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.17 Millimeter FDA UDILength — 0.9 Millimeter FDA UDILength — 1.2 Millimeter FDA UDIOuter Diameter — 0.2 Millimeter FDA UDIOuter Diameter — 0.15 Millimeter FDA UDILength — 0.6 Millimeter FDA UDI
SEIRIN Pyonex Needles by Seirin Corporation — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4547248SPN001X6 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4547248SPN001X6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Seirin Corporation
- EUDAMED SRN
- JP-MF-000012274
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED e909a539-93e2-426b-adb0-870c5530315f 61 fields · synced Jul 27, 2026
- EUDAMED 011af457-e60c-4664-ba72-d7a64d3e3f81 61 fields · synced May 17, 2026
- EUDAMED 80123c37-ba08-443d-ab34-6b5c601308a0 61 fields · synced May 17, 2026
- EUDAMED 819db276-82bc-481b-a760-18a46b529346 61 fields · synced May 18, 2026
- FDA UDI bf65f9b2-d01b-435a-a657-163d1e75813c 35 fields · synced May 30, 2026
- FDA UDI 099aeb75-8d26-425b-86f9-f9f50d3436fb 35 fields · synced May 30, 2026
- FDA UDI b450b6ba-3f6a-4be8-96cb-10d5f1e48966 35 fields · synced May 30, 2026
- EUDAMED bd8444bd-376f-4f2b-9f95-60f5993929cf 61 fields · synced Jul 15, 2026
- EUDAMED 56258d7f-0805-4afa-88ae-821d13152d92 61 fields · synced Jul 25, 2026