Fußschalter, 3 Taster
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Fußschalter, 3 Taster EUDAMEDLocalite TMS Navigator TS FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Model / Reference
- Fußschalter EUDAMED001164 EUDAMEDFoot switch, 3 Pedals FDA UDI
Identifiers
- Catalog Number
- 001164 FDA UDI
- Primary DI / UDI-DI
- +G076A001164A0 EUDAMEDG076A001164A0 FDA UDI
- Basic UDI-DI
- ++G076D192 EUDAMED
- 510(k) Number
- K223577 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
Fußschalter, 3 Taster by LOCALITE GmbH — 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 | ++G076D192 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Localite GmbH
- EUDAMED SRN
- DE-MF-000005419
Sources (2)
- EUDAMED 1dd44506-c3b7-450e-b9f5-60346a4702b2 61 fields · synced Jul 12, 2026
- FDA UDI c0cf89af-741f-4f8f-834f-3643ece05415 34 fields · synced May 30, 2026