Identity
- Trade Name
- B.Box Classic EUDAMEDBEMER Therapy Systems FDA UDI
- Generic Name
- Hand-held deep-tissue electromagnetic stimulator FDA UDI
- Device Name
- B.Box Classic EUDAMED
- Model / Reference
- 420100 EUDAMEDB.BOX Classic FDA UDI
Identifiers
- Catalog Number
- 420100 FDA UDI
- Primary DI / UDI-DI
- 07640161462014 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640161462014 EUDAMED
- FDA Product Code
- ISA FDA UDINGX 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 I FDA UDI
- Regulation Number
- 890.5660 FDA UDI890.5850 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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.Box Classic by Bemer Int. AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640161462014 | 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 8ba39525-01cb-4a3b-ba73-77fba1bcb216 61 fields · synced Jun 19, 2026
- FDA UDI cb9f52c6-a602-458a-875e-4802929561a5 33 fields · synced May 30, 2026