Horizon 3.0 Coil Holder
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Horizon 3.0 Coil Holder EUDAMEDFDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- AFC Support Stand EUDAMED
- Model / Reference
- 4735-00 EUDAMED5835-00-50 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229533012 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060229530025Y EUDAMED
- Direct Marketing DI
- 05060229533012 EUDAMED
- 510(k) Number
- K211389 FDA UDI
- FDA Product Code
- OBP FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class I 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Horizon 3.0 Coil Holder by The Magstim Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5060229530025Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 a7d6d266-9f70-416c-a6e7-c21f301542a1 61 fields · synced Jun 18, 2026
- FDA UDI 1980ef1b-0600-44d9-bb53-e60ad09feaa0 34 fields · synced May 30, 2026