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-Type acupuncture needle is renowned for its role in producing gentle, painless and stress-free treatments. Made from the highest quality stainless steel, it features a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. With Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. Box of 100 sterile, disposable needles. FDA UDI
Model / Reference: J-Type (J-Sakura) No.2(0.18)x50mm FDA UDI
Description: The J-Type acupuncture needle is renowned for its role in producing gentle, painless and stress-free treatments. Made from the highest quality stainless steel, it features a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. With Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. Box of 100 sterile, disposable needles. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547248700188 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: Length — 50 Millimeter FDA UDI
Outer Diameter — 0.18 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 0801c8bc-70c2-4a25-9e08-ab09430ab109 35 fields · synced May 30, 2026