Identity
- Trade Name
- Horizon User Interface EUDAMEDHORIZON™ User Interface FDA UDI
- Generic Name
- Magnetic neural stimulation system, stationary FDA UDI
- Device Name
- Horizon User Interface EUDAMEDRepetitive Pulse Magnetic Stimulator Systems (Horizon Family Systems) EUDAMED
- Model / Reference
- 5048-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229532299 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060229532299 EUDAMED5060229530115Z EUDAMED
- FDA Product Code
- OBP FDA UDI
- EMDN Code
- Z12101105 MAGNETIC STIMULATORS EUDAMED
- GMDN Term
- Magnetic neural stimulation system, stationary FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5805 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Horizon User Interface by The Magstim Company Limited — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060229532299 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060229532299 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- The Magstim Company Limited
- EUDAMED SRN
- GB-MF-000003956
- Authorised Representative
- Technomed Europe NL-AR-000002048
Sources (3)
- EUDAMED 965631e0-3e14-4573-8ab4-04bcba352267 61 fields · synced Jul 16, 2026
- EUDAMED 8817382a-2dd1-4ece-a3eb-67e52efa69f9 61 fields · synced May 19, 2026
- FDA UDI 660b06a6-61ef-4c6e-ad41-67c7bb0f8c44 34 fields · synced May 30, 2026