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Apollo TMS Therapy System 115 V
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 918001Model Apollo TMS Therapy System
Identity
- Trade Name
- Apollo TMS Therapy System 115 V EUDAMEDApollo TMS Therapy System FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Model / Reference
- Apollo TMS Therapy System EUDAMED918001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260526050019 EUDAMEDFDA UDI
- Basic UDI-DI
- 426052605APOLLO91836 EUDAMED
- Direct Marketing DI
- 04260526050019 EUDAMED
- FDA Product Code
- OBP FDA UDI
- EMDN Code
- Z12101105 MAGNETIC STIMULATORS EUDAMED
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5805 FDA UDI
- Market of Registration
- Germany 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
Apollo TMS Therapy System 115 V by MAG & More GmbH — Class IIa — 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 | 426052605APOLLO91836 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MAG & More GmbH
- EUDAMED SRN
- DE-MF-000012125
Sources (2)
- EUDAMED 1db18ee3-1ce4-4362-901d-2b28ef86535b 61 fields · synced Jun 17, 2026
- FDA UDI c02a3332-52c5-4cfe-a9bb-9e370951b018 32 fields · synced May 30, 2026