Identity
- Trade Name
- B.Spot Evo EUDAMEDFDA UDI
- Generic Name
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
- Device Name
- PEMF Applicators EUDAMED
- Model / Reference
- 434000 EUDAMEDBEMER Therapy System Evo FDA UDI
Identifiers
- Catalog Number
- 434000 FDA UDI
- Primary DI / UDI-DI
- 07640161460188 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016146PEMFD8 EUDAMED
- Direct Marketing DI
- 07640161460188 EUDAMED
- 510(k) Number
- K231368 FDA UDI
- FDA Product Code
- NGX FDA UDI
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
- GMDN Term
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Market of Registration
- Liechtenstein 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
B.Spot Evo by Bemer Int. AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016146PEMFD8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BEMER Int. AG
- EUDAMED SRN
- LI-MF-000002555
Sources (2)
- EUDAMED 3c614c98-528a-4050-acfc-45b4adcdc66d 61 fields · synced Jun 18, 2026
- FDA UDI 5d45eb65-172f-446d-9161-e50e2be0858a 34 fields · synced May 30, 2026