Identity
- Trade Name
- TCMzoneHuaTuo FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- TCL Type Acupuncture Needle 0.14mm x 25mm Copper and Loop Handle 1 needle per tube 100needles/box FDA UDI
- Model / Reference
- TCL Type 0.14mm x 25mm FDA UDI
- Description
- TCL Type Acupuncture Needle 0.14mm x 25mm Copper and Loop Handle 1 needle per tube 100needles/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810202812055 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
Yes
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
TCMzoneHuaTuo by TCMZone, LLC — 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
- TCMZone, LLC
Sources (1)
- FDA UDI 3a31de27-c1a0-4af7-84d7-0f0b3a77136d 33 fields · synced Jun 8, 2026