Identity
- Trade Name
- Horizon 3.0 MEP Pod EUDAMEDFDA UDI
- Generic Name
- Clinical management support software FDA UDI
- Device Name
- Repetitive Pulse Magnetic Stimulator Systems (Horizon Family Systems) EUDAMED
- Model / Reference
- 6261-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229533074 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060229530115Z EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z12101105 MAGNETIC STIMULATORS EUDAMED
- GMDN Term
- Clinical management support software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 880.6310 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Horizon 3.0 MEP Pod 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Magstim Company Limited
- EUDAMED SRN
- GB-MF-000003956
- Authorised Representative
- Technomed Europe NL-AR-000002048
Sources (2)
- EUDAMED e3c77d40-ea9b-4046-adce-1043b3c55fb7 61 fields · synced Jul 9, 2026
- FDA UDI 679edb79-cbda-4e9e-ad6b-ee316e0bac5f 33 fields · synced May 30, 2026