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SEIRIN SPINEX Intradermal Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NS No.01(0.14)x5mm
Identity
- Trade Name
- SEIRIN SPINEX NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- SEIRIN SPINEX Intradermal Needles EUDAMEDAn essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 needles. FDA UDI
- Model / Reference
- NS No.01(0.14)x5mm EUDAMEDFDA UDI
- Description
- An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248500092 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04547248500092 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
- Outer Diameter — 0.14 Millimeter FDA UDILength — 5 Millimeter FDA UDI
SEIRIN SPINEX Intradermal 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-04547248500092 | 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 39b43b0a-701c-4f14-bfaf-df0f946f5ba1 61 fields · synced May 30, 2026
- FDA UDI 077b495a-67d8-4309-ab0b-ceed1054dabb 35 fields · synced May 30, 2026