SMC acupuncture needle

FDA UDI

Class II (US FDA UDI)

by SMC Ltd.

Identity

Trade Name: SMC acupuncture needle FDA UDI
Generic Name: Acupuncture needle, single-use FDA UDI
Device Name: SMC acupuncture needle 0.22*30 (1,000pcs/Box) 25mm Handle SMC's sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality. FDA UDI
Model / Reference: 02203025 FDA UDI
Description: SMC acupuncture needle 0.22*30 (1,000pcs/Box) 25mm Handle SMC's sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800020300218 FDA UDI
510(k) Number: K141473 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Acupuncture needle, single-use

SMC acupuncture needle by SMC Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Acupuncture needle, single-use.

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AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
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Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II

Cleared under the same submission

K141473 also covers:

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: SMC Ltd.

Sources (1)

FDA UDI 00b6ae08-2225-43dc-b3a2-e9d410d93c0d 35 fields · synced Jun 1, 2026