Identity
- Trade Name
- Haeng Lim Acupuncture Needles FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Haeng Lim Spring Handle Acupuncture Needle, 0.25㎜-105㎜, Inner Package FDA UDI
- Model / Reference
- HL-00125105C FDA UDI
- Description
- Haeng Lim Spring Handle Acupuncture Needle, 0.25㎜-105㎜, Inner Package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809266933983 FDA UDI
- 510(k) Number
- K092240 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Haeng Lim Acupuncture Needles by Heng Lim Seowon Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture needle, single-use.
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- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- 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
K092240 also covers:
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
- Haeng Lim Acupuncture Needles — Heng Lim Seowon Medical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heng Lim Seowon Medical
Sources (1)
- FDA UDI 5a2485bc-afd3-4f20-bd13-b2c7f0198bc1 34 fields · synced May 30, 2026