Identity
- Trade Name
- Horizon Air Film Coil EUDAMEDHORIZON™ Air Film Coil FDA UDI
- Generic Name
- Magnetic neural stimulation system, stationary FDA UDI
- Device Name
- Horizon Air Film Coil EUDAMED
- Model / Reference
- 4980-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229532268 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060229532268 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 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
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
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 Air Film Coil by The Magstim Company Limited — 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-05060229532268 | 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 (2)
- EUDAMED 16975c73-815f-4631-b254-88f4232de451 61 fields · synced Oct 6, 2026
- FDA UDI f9f5c73f-ca2d-4450-a6ad-caa8377f5cc1 34 fields · synced May 30, 2026