Identity
- Trade Name
- Horizon 3.0 Stimulator EUDAMEDHorizon 3.0 Mainframe FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- Repetitive Pulse Magnetic Stimulator Systems (Horizon Family Systems) EUDAMED
- Model / Reference
- 5800-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229532695 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060229530115Z EUDAMED
- 510(k) Number
- K211389 FDA UDI
- FDA Product Code
- OBP FDA UDI
- EMDN Code
- Z12101105 MAGNETIC STIMULATORS EUDAMED
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class 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 3.0 Stimulator by The Magstim Company Limited — Class IIb — 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 | 5060229530115Z | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (2)
- EUDAMED 7e3f6de2-6af2-44d4-a4be-0ac98036f754 61 fields · synced Aug 2, 2026
- FDA UDI b0c7e45d-3cb0-4690-b098-9e2a2cb3413c 34 fields · synced May 30, 2026