Seirin Acupuncture Needle

FDA UDI

Class II (US FDA UDI)

by Seirin Corporation

Identity

Trade Name: SEIRIN ACUPUNCTURE NEEDLE FDA UDI
Generic Name: Acupuncture needle, single-use FDA UDI
Device Name: The 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: J15 (J-Sakura) No.1(0.16)x15mm FDA UDI
Description: The 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: 04547248705107 FDA UDI
FDA Product Code: MQX FDA UDI
GMDN Term: Acupuncture needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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 — 0.16 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Acupuncture needle, single-use

Seirin Acupuncture Needle by Seirin Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Seirin Corporation

Sources (1)

FDA UDI 0509c3bd-7ecf-4cfa-8e41-d26a07f05b72 35 fields · synced May 31, 2026