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SEIRIN Acupuncture Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J-Type No.8(0.30)x30mmRef B-Type No.8(0.30)x50mmRef L-Type No.5(0.25)x30mmRef L-Type No.4(0.23)x40mmRef J-Type No.2(0.18)x50mmRef L-Type No.3(0.20)x30mmRef J-Type No.02(0.12)x30mmRef G-Type No.8(0.30)x75mmRef J-Type No.3(0.20)x60mmRef B-Type No.8(0.30)x30mmRef J-Type No.5(0.25)x60mmRef G-Type No.5(0.25)x90mmRef L-Type No.8(0.30)x50mmRef J-Type No.8(0.30)x60mmRef L-Type No.3(0.20)x50mmRef J-Type No.2(0.18)x40mmRef J-Type No.3(0.20)x40mmRef J-Type No.3(0.20)x30mmRef G-Type No.10(0.35)x90mmRef G-Type No.5(0.25)x40mmRef L-Type No.5(0.25)x50mmRef B-Type No.3(0.20)x15mmRef J15 No.1(0.16)×15mmRef B-type No.1(0.16) x15mmRef J15 No.1(0.16)x15mmRef B-Type No.1(0.16)x15mmRef J-Type No.3(0.20) x30mmRef J-Type No.3(0.20) 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 UDIThe 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 UDIThe Laser sharp L-Type needles from SEIRIN offer practitioners a painless choice for moxibustion or electro-therapy treatments. The L-Type features a flexible 1.3 x 20 mm metal spring type handle, optimal for conducting electricity and heat during use. It also provides the practitioner with an enhanced grip, for a precise treatment. Made up entirely of surgical stainless steel, the L-Type upholds SEIRIN's long tradition of innovation, quality, and safety. 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 UDIThe J-15 is perfect for facial, auricular, hand acupuncture, or wherever shallow needling is performed. Available in the thinnest gauges you can find (03, 02, 01, and 1), this 15 mm needle comes with rounded guide tubes for accurate, gentle, painless and stress-free acupuncture. The J-15 also features ProPak™ technology, which allows you to open one or more blister packs quickly and easily. One surgical stainless steel needle per blister package. Features lightweight, color coded, 2.0 x 20 mm easy release comfort grip plastic handle with Light Touch Insertion. Sterile, disposable. Box of 100 needles. FDA UDI
- Model / Reference
- J-Type No.8(0.30)x30mm EUDAMEDFDA UDIB-Type No.8(0.30)x50mm EUDAMEDL-Type No.5(0.25)x30mm EUDAMEDFDA UDIL-Type No.4(0.23)x40mm EUDAMEDFDA UDIJ-Type No.2(0.18)x50mm EUDAMEDFDA UDIL-Type No.3(0.20)x30mm EUDAMEDFDA UDIJ-Type No.02(0.12)x30mm EUDAMEDFDA UDIG-Type No.8(0.30)x75mm EUDAMEDFDA UDIJ-Type No.3(0.20)x60mm EUDAMEDFDA UDIB-Type No.8(0.30)x30mm EUDAMEDJ-Type No.5(0.25)x60mm EUDAMEDFDA UDIG-Type No.5(0.25)x90mm EUDAMEDFDA UDIL-Type No.8(0.30)x50mm EUDAMEDFDA UDIJ-Type No.8(0.30)x60mm EUDAMEDFDA UDIL-Type No.3(0.20)x50mm EUDAMEDFDA UDIJ-Type No.2(0.18)x40mm EUDAMEDFDA UDIJ-Type No.3(0.20)x40mm EUDAMEDFDA UDIJ-Type No.3(0.20)x30mm EUDAMEDFDA UDIG-Type No.10(0.35)x90mm EUDAMEDFDA UDIG-Type No.5(0.25)x40mm EUDAMEDFDA UDIL-Type No.5(0.25)x50mm EUDAMEDFDA UDIB-Type No.3(0.20)x15mm EUDAMEDJ15 No.1(0.16)×15mm EUDAMEDJ15 No.1(0.16)x15mm EUDAMEDFDA UDIB-type No.1(0.16) x15mm EUDAMEDB-Type No.1(0.16)x15mm EUDAMEDJ-Type No.3(0.20) x30mm EUDAMEDJ-Type No.3(0.20) x40mm EUDAMED
- 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 UDIThe 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 UDIThe Laser sharp L-Type needles from SEIRIN offer practitioners a painless choice for moxibustion or electro-therapy treatments. The L-Type features a flexible 1.3 x 20 mm metal spring type handle, optimal for conducting electricity and heat during use. It also provides the practitioner with an enhanced grip, for a precise treatment. Made up entirely of surgical stainless steel, the L-Type upholds SEIRIN's long tradition of innovation, quality, and safety. 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 UDIThe J-15 is perfect for facial, auricular, hand acupuncture, or wherever shallow needling is performed. Available in the thinnest gauges you can find (03, 02, 01, and 1), this 15 mm needle comes with rounded guide tubes for accurate, gentle, painless and stress-free acupuncture. The J-15 also features ProPak™ technology, which allows you to open one or more blister packs quickly and easily. One surgical stainless steel needle per blister package. Features lightweight, color coded, 2.0 x 20 mm easy release comfort grip plastic handle with Light Touch Insertion. Sterile, disposable. Box of 100 needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248110482 EUDAMEDFDA UDI04547248011505 EUDAMED04547248210397 EUDAMEDFDA UDI04547248210311 EUDAMEDFDA UDI04547248110185 EUDAMEDFDA UDI04547248210212 EUDAMEDFDA UDI04547248110055 EUDAMEDFDA UDI04547248116521 EUDAMEDFDA UDI04547248110246 EUDAMEDFDA UDI04547248011482 EUDAMED04547248110420 EUDAMEDFDA UDI04547248116446 EUDAMEDFDA UDI04547248210502 EUDAMEDFDA UDI04547248110512 EUDAMEDFDA UDI04547248210236 EUDAMEDFDA UDI04547248110178 EUDAMEDFDA UDI04547248110222 EUDAMEDFDA UDI04547248110215 EUDAMEDFDA UDI04547248116620 EUDAMEDFDA UDI04547248116408 EUDAMEDFDA UDI04547248210410 EUDAMEDFDA UDI04547248011208 EUDAMED04547248131104 EUDAMEDFDA UDI04547248011109 EUDAMED
- Basic UDI-DI
- 4547248SAN001RZ EUDAMEDB-04547248011505 EUDAMEDB-04547248210311 EUDAMEDB-04547248110055 EUDAMEDB-04547248210236 EUDAMEDB-04547248110222 EUDAMEDB-04547248110215 EUDAMEDB-04547248116620 EUDAMEDB-04547248116408 EUDAMEDB-04547248210410 EUDAMEDB-04547248011208 EUDAMEDB-04547248210397 EUDAMEDB-04547248110482 EUDAMEDB-04547248210212 EUDAMEDB-04547248011109 EUDAMEDB-04547248131104 EUDAMEDB-04547248110185 EUDAMEDB-04547248110178 EUDAMEDB-04547248110420 EUDAMEDB-04547248116521 EUDAMEDB-04547248116446 EUDAMEDB-04547248210502 EUDAMEDB-04547248110246 EUDAMED
- Unit of Use DI
- 24547248110486 EUDAMED24547248210391 EUDAMED24547248110189 EUDAMED24547248210216 EUDAMED24547248116525 EUDAMED24547248110240 EUDAMED24547248011486 EUDAMED24547248110424 EUDAMED24547248116440 EUDAMED24547248210506 EUDAMED24547248110516 EUDAMED24547248110172 EUDAMED24547248131108 EUDAMED24547248210230 EUDAMED24547248011202 EUDAMED24547248210315 EUDAMED24547248116402 EUDAMED24547248011509 EUDAMED24547248210414 EUDAMED24547248011103 EUDAMED24547248110219 EUDAMED24547248110059 EUDAMED24547248116624 EUDAMED24547248110226 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 — 30 Millimeter FDA UDIOuter Diameter — 0.12 Millimeter FDA UDIOuter Diameter — 0.30 Millimeter FDA UDILength — 75 Millimeter FDA UDIOuter Diameter — 0.25 Millimeter FDA UDILength — 60 Millimeter FDA UDIOuter Diameter — 0.16 Millimeter FDA UDILength — 15 Millimeter FDA UDIOuter Diameter — 0.20 Millimeter FDA UDIOuter Diameter — 0.35 Millimeter FDA UDILength — 90 Millimeter FDA UDILength — 50 Millimeter FDA UDILength — 40 Millimeter FDA UDIOuter Diameter — 0.23 Millimeter FDA UDIOuter Diameter — 0.18 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 (66)
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