Identity
- Trade Name
- POINTER PAL FDA UDI
- Generic Name
- Acupuncture point detector FDA UDI
- Device Name
- Pointer Pal EUDAMED
- Model / Reference
- ED3331 EUDAMEDPt.Pal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14897076720221 EUDAMEDFDA UDI
- Basic UDI-DI
- 489707672PALUX EUDAMED
- FDA Product Code
- BWJ FDA UDI
- EMDN Code
- N010202 STIMULATION POINT LOCATORS EUDAMED
- GMDN Term
- Acupuncture point detector FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Acupuncture point detector
Pointer Pal by Tens Plus Industrial Company — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Acupuncture point detector.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tens Plus Industrial Company
Sources (2)
- FDA UDI 3bb8840a-6f69-4cbe-84f4-74ddbc4ac673 32 fields · synced Jul 9, 2026
- EUDAMED 83e29e06-2258-4f4f-a386-1bf666f2e6fa 61 fields · synced Jul 9, 2026