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: SEIRIN D-Type needles are a perfect choice for gentle, painless and stress-free acupuncture treatments where shallow needling is performed. Similar in style to the J-Type, the D-Type needle is available only in a length of 15 mm and does not have guide tubes, which make it ideal for freehand techniques. The color-coded 2.0 x 20 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles. FDA UDI
Model / Reference: D-Type (D-Kaede) No.3(0.20)x15mm FDA UDI
Description: SEIRIN D-Type needles are a perfect choice for gentle, painless and stress-free acupuncture treatments where shallow needling is performed. Similar in style to the J-Type, the D-Type needle is available only in a length of 15 mm and does not have guide tubes, which make it ideal for freehand techniques. The color-coded 2.0 x 20 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547248176204 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 — 15 Millimeter FDA UDI
Outer Diameter — 0.20 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 bd2970d2-2754-4ddc-a5c5-a64b9d7b07c1 35 fields · synced May 30, 2026