Identity
- Trade Name
- Pointer EUDAMEDLocalite TMS Navigator TS FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Device Name
- Pointer EUDAMED
- Model / Reference
- Pointer EUDAMEDFDA UDI001111 EUDAMED
Identifiers
- Catalog Number
- 001111 FDA UDI
- Primary DI / UDI-DI
- +G076A001111A08 EUDAMEDG076A001111A0 FDA UDI
- Basic UDI-DI
- ++G076J19L 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Device sterilization/disinfection container, reusable
Pointer 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G076J19L | 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 d39f2a36-6184-4f35-b8d6-2650b11d13ea 61 fields · synced Jul 30, 2026
- FDA UDI c0081061-11aa-4340-87fb-22d045ca51b3 34 fields · synced May 30, 2026