Identity
- Trade Name
- Trackerring, 25 mm EUDAMEDLocalite TMS Navigator TS FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Model / Reference
- Tracker EUDAMED014221 EUDAMEDTracker Bracket, 25 mm FDA UDI
Identifiers
- Catalog Number
- 014221 FDA UDI
- Primary DI / UDI-DI
- +G076A014221A0 EUDAMEDG076A014221A0 FDA UDI
- Basic UDI-DI
- ++G076K19P 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
Trackerring, 25 mm 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 | ++G076K19P | 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 5f54cbbe-b0f9-40fd-aab8-7dedfcfb9ee8 61 fields · synced Jul 8, 2026
- FDA UDI cfbe90fe-e3c7-48f6-9af1-e70a59f8d1d4 34 fields · synced May 30, 2026