SEIRIN SPINEX Intradermal Needles

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref NS No.01(0.14)x6mm

by Seirin Corporation

Identity

Trade Name: SEIRIN SPINEX NEEDLE FDA UDI
Generic Name: Acupuncture needle, single-use FDA UDI
Device Name: SEIRIN SPINEX Intradermal Needles EUDAMED
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
Model / Reference: NS No.01(0.14)x6mm 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: 04547248500108 EUDAMEDFDA UDI
Basic UDI-DI: B-04547248500108 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 EUDAMED
Class 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

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 0.14 Millimeter FDA UDI
Length — 6 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-04547248500108	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 0e84cc45-3597-44c6-8643-7006b37c1c0d 61 fields · synced May 30, 2026
FDA UDI ae5cd2b9-9be9-4703-a0f0-7acd2cffeba3 35 fields · synced May 30, 2026