Planar Field Generator with Stand
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Planar Field Generator with Stand EUDAMEDPercunav Planar Field Generator with Stand FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- PercuNav Field Generator EUDAMED
- Model / Reference
- 989606710361 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838099432 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM437T5 EUDAMED
- FDA Product Code
- JAK FDA UDILLZ FDA UDIIYO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI892.2050 FDA UDI892.1560 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
Yes
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
No
Category: Neurological stereotactic surgery system
Planar Field Generator with Stand by Philips Ultrasound LLC — 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 | 0884838BM437T5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 20860057-f880-4d8f-99a3-8f4dd615c5b4 61 fields · synced Jul 12, 2026
- FDA UDI e4f0aaf6-6290-471a-bb46-667b050c62e1 32 fields · synced May 30, 2026