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SEIRIN Acupuncture Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ELIPEAS No.01(0.14)x7mm
Identity
- Trade Name
- SEIRIN Acupuncture Needles EUDAMEDSEIRIN ACUPUNCTURE NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- SEIRIN Acupuncture Needles EUDAMEDELIPEAS is perfect for facial, auricular acupuncture especially treating the body parts where needles inserted superficially. Stabled needle retention with less-weighed-handle. ELIPEAS is available only in a length of 7mm and does not have guide tubes, which makes it ideal for freehand techniques. 4 needles per plastic case. This plastic case not only preserves the needle but also converts into both standing and portable functional dispenser by folding it. The color-coded 18 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles. FDA UDI
- Model / Reference
- ELIPEAS No.01(0.14)x7mm EUDAMEDFDA UDI
- Description
- ELIPEAS is perfect for facial, auricular acupuncture especially treating the body parts where needles inserted superficially. Stabled needle retention with less-weighed-handle. ELIPEAS is available only in a length of 7mm and does not have guide tubes, which makes it ideal for freehand techniques. 4 needles per plastic case. This plastic case not only preserves the needle but also converts into both standing and portable functional dispenser by folding it. The color-coded 18 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248140076 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547248SAN001RZ EUDAMED
- Unit of Use DI
- 24547248140070 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 — 0.14 Millimeter FDA UDILength — 7 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 7bfa24d5-4e24-43ac-9382-24b7e06426a0 61 fields · synced Jul 30, 2026
- FDA UDI e604cf7c-5cfe-4037-bb7b-2bcf590e5bd6 35 fields · synced May 30, 2026