Identity
- Trade Name
- HA FlexTrak II EUDAMEDIngenia FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- Trolley, Acoustic Hood and Tabletop extender EUDAMEDThe HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. FDA UDI
- Model / Reference
- 989710008732 EUDAMEDHA FlexTrak II FDA UDI
- Description
- The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. FDA UDI
Identifiers
- Catalog Number
- 989710008732 FDA UDI
- Primary DI / UDI-DI
- 00884838099500 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM474TB EUDAMED
- Direct Marketing DI
- 00884838099500 EUDAMED
- 510(k) Number
- K213583 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
HA FlexTrak II by Philips Medical Systems Nederland B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0884838BM474TB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 50634619-b0e2-4d61-acde-3d354baf31ca 61 fields · synced Oct 6, 2026
- FDA UDI 1d8d8a0c-46bd-477e-844a-84d58d8ff340 36 fields · synced May 30, 2026