Identity
- Trade Name
- D70mm Air Film SHAM Coil EUDAMEDMagstim Double 70mm Air Film Coil FDA UDI
- Generic Name
- Magnetic neural stimulation placebo FDA UDI
- Device Name
- Double 70mm Placebo Air Film Coil EUDAMEDFDA UDI
- Model / Reference
- 3950-00 EUDAMEDFDA UDI
- Description
- Double 70mm Placebo Air Film Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060229530868 EUDAMEDFDA UDI
- Basic UDI-DI
- 50602295300362 EUDAMED
- FDA Product Code
- GWF FDA UDIOBP FDA UDI
- EMDN Code
- Z120606 MAGNETOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Magnetic neural stimulation placebo FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.5805 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
D70mm Air Film SHAM Coil by The Magstim Company Limited — Class I — 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 | 50602295300362 | 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 2f9b6fdc-0a9a-4fbb-a6ce-b99a7fac72bf 61 fields · synced Jul 20, 2026
- FDA UDI ecaa0cdf-ad01-4e1b-bf72-be4205fd8c78 34 fields · synced May 29, 2026