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SEIRIN Acupuncture Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J-Type No.8(0.30)x40mm
Identity
- Trade Name
- SEIRIN Acupuncture Needles EUDAMEDSEIRIN ACUPUNCTURE NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- SEIRIN Acupuncture Needles EUDAMEDThe J-Type acupuncture needle is renowned for its role in producing gentle, painless and stress-free treatments. Made from the highest quality stainless steel, it features a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. With Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. Box of 100 sterile, disposable needles. FDA UDI
- Model / Reference
- J-Type No.8(0.30)x40mm EUDAMEDFDA UDI
- Description
- The J-Type acupuncture needle is renowned for its role in producing gentle, painless and stress-free treatments. Made from the highest quality stainless steel, it features a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. With Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. Box of 100 sterile, disposable needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248110499 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547248SAN001RZ EUDAMEDB-04547248110499 EUDAMED
- Unit of Use DI
- 24547248110493 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
- Length — 40 Millimeter FDA UDIOuter Diameter — 0.30 Millimeter FDA UDI
SEIRIN Acupuncture 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 | 4547248SAN001RZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4547248SAN001RZ | 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 (3)
- EUDAMED 8696c3cf-162d-43f2-912e-0ecfa3f0ac5b 61 fields · synced Jun 8, 2026
- EUDAMED 5c8fe8cb-bc5d-4173-a0a0-b58ef10d9f49 61 fields · synced May 17, 2026
- FDA UDI 49c9d8dc-2ddf-4f57-a64c-9e1cbace350c 35 fields · synced May 29, 2026