Identity
- Trade Name
- ASIA MED FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- asia-med Apex Steel: uncoated semi-permanent acupuncture needles with applicator and magnet.|Incl. 100 plasters|Packaging: 1 needle per blister|Size (needle): 1,3 x 3.2 mm|Sales unit: 100 pieces FDA UDI
- Model / Reference
- Apex FDA UDI
- Description
- asia-med Apex Steel: uncoated semi-permanent acupuncture needles with applicator and magnet.|Incl. 100 plasters|Packaging: 1 needle per blister|Size (needle): 1,3 x 3.2 mm|Sales unit: 100 pieces FDA UDI
Identifiers
- Catalog Number
- A000557 FDA UDI
- Primary DI / UDI-DI
- 04251282513467 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
- Not 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 — 3.2 Millimeter FDA UDIOuter Diameter — 1.3 Millimeter FDA UDI
Asia Med by asia-med GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 ab611fc1-3bb7-4892-8760-4e1725c687c5 38 fields · synced Jun 7, 2026