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HUAN QIU Acupuncture needle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0.20×25mmModel 0.16×10mm
Identity
- Trade Name
- HUAN QIU EUDAMEDHUAN QIU Acupuncture needle FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Disposable Acupuncture Needles EUDAMEDStainless steel flat handle acupuncture needle, one needle with one tube in one blister,100pcs/box. FDA UDI
- Model / Reference
- 0.16×10mm EUDAMED0.20×25mm EUDAMED0.35×100mm FDA UDI
- Description
- Stainless steel flat handle acupuncture needle, one needle with one tube in one blister,100pcs/box. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975998180031 EUDAMED06975998180024 EUDAMED16956418902546 FDA UDI
- Basic UDI-DI
- 697599818RNS01468 EUDAMED
- 510(k) Number
- K011242 FDA UDI
- FDA Product Code
- MQX FDA UDI
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Market of Registration
- Portugal EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Acupuncture needle, single-use
HUAN QIU Acupuncture needle by Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Acupuncture needle, single-use.
- Energy Flo Value-Pak J Type Acupuncture Needles — Acu Market · Class II
- ASIA MED — asia-med GmbH · Class II
- CARBO — WuJiang City Cloud&Dragon Medical Device Co., Ltd. · Class II
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd. · Class II
- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
- ASIA MED — asia-med GmbH · Class II
- Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
Cleared under the same submission
K011242 also covers:
- HUAN QIU Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- HUAN QIU Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- HUAN QIU Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- Huanqiu — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- Huanqiu — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
- YI SHEN BIAN QUE Acupuncture needle — Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (3)
- FDA UDI f1c4a92d-69e6-4319-a867-4a1e4e6cfe85 34 fields · synced Sep 18, 2026
- EUDAMED eb6f8e02-8c71-4482-bbc7-e2c56f2f5f1f 61 fields · synced Jul 11, 2026
- EUDAMED bbc7024f-3d38-4608-9083-77846a6834a0 61 fields · synced Sep 18, 2026