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TMS Navigator SW MR-Based
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 010205Model TMS Navigator Software 3
Identity
- Trade Name
- TMS Navigator SW MR-Based EUDAMEDLocalite TMS Navigator TS FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Device Name
- TMS Navigator Software EUDAMED
- Model / Reference
- TMS Navigator Software 3 EUDAMED010205 EUDAMEDTMS Navigator SW MR-Based FDA UDI
Identifiers
- Catalog Number
- 10205 FDA UDI
- Primary DI / UDI-DI
- G076A010205AM3N30 EUDAMEDFDA UDI
- Basic UDI-DI
- ++G076A18R EUDAMED
- 510(k) Number
- K223577 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TMS Navigator SW MR-Based by LOCALITE 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 | ++G076A18R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Localite GmbH
- EUDAMED SRN
- DE-MF-000005419
Sources (2)
- EUDAMED 62ceb46b-65a3-4e75-9316-6f9cf85b0154 61 fields · synced Jun 18, 2026
- FDA UDI 16149720-29e8-4e6b-bf62-29025902a184 35 fields · synced May 30, 2026