Identity
- Trade Name
- ASIA MED FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- asia-med PTN - large: uncoated semi-permanent acupuncture Press Tack Needle (PTN)|Packaging: 10 needles on plastic carrier|Size: Gauge 5(x 0.07") / 0.26 x 1.8 mm|Sales unit: 100 pieces FDA UDI
- Model / Reference
- PTN - large FDA UDI
- Description
- asia-med PTN - large: uncoated semi-permanent acupuncture Press Tack Needle (PTN)|Packaging: 10 needles on plastic carrier|Size: Gauge 5(x 0.07") / 0.26 x 1.8 mm|Sales unit: 100 pieces FDA UDI
Identifiers
- Catalog Number
- A000555 FDA UDI
- Primary DI / UDI-DI
- 04251282511562 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.8 Millimeter FDA UDIOuter Diameter — 0.26 Millimeter FDA UDI
Category: Acupuncture needle, single-use
Asia Med by asia-med GmbH — 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
- asia-med GmbH
Sources (1)
- FDA UDI d29aafee-fcee-467a-9d1c-b0b4808731eb 37 fields · synced May 31, 2026