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SEIRIN Acupuncture Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref D-Type No.3(0.20)x15mm
Identity
- Trade Name
- SEIRIN ACUPUNCTURE NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- SEIRIN Acupuncture Needles EUDAMEDSEIRIN D-Type needles are a perfect choice for gentle, painless and stress-free acupuncture treatments where shallow needling is performed. Similar in style to the J-Type, the D-Type needle is available only in a length of 15 mm and does not have guide tubes, which make it ideal for freehand techniques. The color-coded 2.0 x 20 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles. FDA UDI
- Model / Reference
- D-Type No.3(0.20)x15mm EUDAMEDFDA UDI
- Description
- SEIRIN D-Type needles are a perfect choice for gentle, painless and stress-free acupuncture treatments where shallow needling is performed. Similar in style to the J-Type, the D-Type needle is available only in a length of 15 mm and does not have guide tubes, which make it ideal for freehand techniques. The color-coded 2.0 x 20 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248170202 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04547248170202 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — 15 Millimeter FDA UDIOuter Diameter — 0.20 Millimeter FDA UDI
SEIRIN Acupuncture Needles by Seirin Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04547248170202 | 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 7b7ddc95-4501-45f7-b3f6-39f8ab61dfe2 61 fields · synced Aug 1, 2026
- FDA UDI 177fbc4a-5bdd-4f6f-99bc-c0158ad40192 35 fields · synced May 30, 2026