YI SHEN BIAN QUE Acupuncture needle

FDA UDI

Class II (US FDA UDI)

by Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.

Identity

Trade Name: YI SHEN BIAN QUE Acupuncture needle FDA UDI
Generic Name: Acupuncture needle, single-use FDA UDI
Device Name: Stainless steel flat handle acupuncture needle, ten needles and one tube in one blister,1000pcs/box. FDA UDI
Model / Reference: 0.18×15mm FDA UDI
Description: Stainless steel flat handle acupuncture needle, ten needles and one tube in one blister,1000pcs/box. FDA UDI

Identifiers

Primary DI / UDI-DI: 16956418969600 FDA UDI
510(k) Number: K011242 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

YI SHEN BIAN QUE Acupuncture needle by Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Acupuncture needle, single-use.

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Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II

Cleared under the same submission

K011242 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: Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.

Sources (1)

FDA UDI 81ab5397-072b-4557-be84-019a3e8b2ebf 34 fields · synced Jun 6, 2026