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SEIRIN Acupuncture Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref G-Type No.10(0.35)x75mm
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 G-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 25 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 100% PVC free. Box of 100 sterile, disposable needles. FDA UDI
- Model / Reference
- G-Type No.10(0.35)x75mm EUDAMEDFDA UDI
- Description
- The G-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 25 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 100% PVC free. Box of 100 sterile, disposable needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248116613 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547248SAN001RZ EUDAMED
- Unit of Use DI
- 24547248116617 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 — 0.35 Millimeter FDA UDILength — 75 Millimeter FDA UDI
SEIRIN Acupuncture Needles by Seirin Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (2)
- EUDAMED c9531f6d-a8c1-40dd-9a78-da6668708fac 61 fields · synced May 30, 2026
- FDA UDI 499ef172-4ee4-4f40-8065-199a95aeab38 35 fields · synced May 30, 2026