Identity
- Trade Name
- DUAL PROBE 9.8 MM (3-7/8 ") FDA UDI
- Generic Name
- Static magnetic massager FDA UDI
- Device Name
- Massage Tools EUDAMED
- Model / Reference
- BY2627 EUDAMEDDual.Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14897076720566 EUDAMEDFDA UDI
- Basic UDI-DI
- 489707672BALSR EUDAMED
- FDA Product Code
- LYG FDA UDI
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Static magnetic massager FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Static magnetic massager
Dual Probe 9.8 Mm (3-7/8 ") by Tens Plus Industrial Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tens Plus Industrial Company
Sources (2)
- FDA UDI 8457f795-b586-4975-9896-61d8e1eaacad 32 fields · synced Jun 18, 2026
- EUDAMED c9923394-f77b-4ba2-abd8-b4157115f474 61 fields · synced Jun 18, 2026