Identity
- Trade Name
- Tsun.Meter FDA UDI
- Generic Name
- Acupuncture point detector FDA UDI
- Model / Reference
- BD2361 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14897076720214 FDA UDI
- FDA Product Code
- BWJ FDA UDI
- GMDN Term
- Acupuncture point detector 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acupuncture point detector
Tsun.Meter by Tens Plus Industrial Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture point detector.
- Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- POINT MATE — TENS PLUS INDUSTRIAL COMPANY · Class II
- POINTER PAL — TENS PLUS INDUSTRIAL COMPANY · Class II
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
- Tens Plus Industrial Company
Sources (1)
- FDA UDI eb8e5037-a34d-496e-958f-0cf930bce4b5 32 fields · synced May 30, 2026