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AltaTrack Equipment
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 4322 070 2023 X510(k) K223918
Identity
- Trade Name
- AltaTrack Equipment EUDAMED
- Device Name
- AltaTrack Equipment EUDAMED
- Model / Reference
- 4322 070 2023 X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838090828 EUDAMED
- Basic UDI-DI
- 0884838BM644TC EUDAMED
- 510(k) Number
- K223918 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electromagnetic surgical navigation device tracking system
AltaTrack Equipment by Philips Medical Systems Nederland B.V. — Class I — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0884838BM644TC | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K223918 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM644TC | Class I | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED b7258f3f-0ac7-4647-b365-32f02db98007 61 fields · synced Sep 18, 2026
- FDA 510(k) K223918 24 fields · synced May 18, 2026