Identity
- Trade Name
- Horizon 3.0 ez Cool Coil FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- Horizon 3.0 ez Cool Coil FDA UDI
- Model / Reference
- 5620-00-50 FDA UDI
- Description
- Horizon 3.0 ez Cool Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229533036 FDA UDI
- FDA Product Code
- OBP FDA UDI
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5805 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Magnetic neural stimulation system
Horizon 3.0 ez Cool Coil by The Magstim Company , Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Magnetic neural stimulation system.
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro — Tonica Elektronik A/S · Class II
- CloudTMS Edge for OCD — NEUROSOFT, OOO · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Magstim Company , Ltd.
Sources (2)
- FDA UDI 33bcd3bb-3a5d-4092-86c4-5d1421f203ff 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026