Identity
- Trade Name
- Acoustic hood EUDAMEDIngenia FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- Trolley, Acoustic Hood and Tabletop extender EUDAMED"The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses. The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations. Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." FDA UDI
- Model / Reference
- 989603020982 EUDAMEDAcoustic Hood FDA UDI
- Description
- "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses. The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations. Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." FDA UDI
Identifiers
- Catalog Number
- 989603020982 FDA UDI
- Primary DI / UDI-DI
- 00884838099449 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM474TB EUDAMED
- Direct Marketing DI
- 00884838099449 EUDAMED
- 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
Acoustic hood 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 |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED a9f15c3d-309a-491d-ac6a-fe38f5410b43 61 fields · synced Oct 6, 2026
- FDA UDI 0b8d1ed9-0bd6-48dd-bdca-7d6d6e16bce0 35 fields · synced May 30, 2026