Identity
- Trade Name
- dS Headrest EUDAMEDPhilips Sentinelle FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Philips Breast Coil PMS EUDAMEDdS Headrest FDA UDI
- Model / Reference
- 459801804022 EUDAMEDdS Headrest FDA UDI
- Description
- dS Headrest FDA UDI
Identifiers
- Catalog Number
- 459801804022 FDA UDI
- Primary DI / UDI-DI
- 00884838119369 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM914TJ EUDAMED
- 510(k) Number
- K213735 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001,Z1105018002,Z1105018099 EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa 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
dS Headrest by Philips Medical Systems Nederland B.V. — Class IIa — 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 | 0884838BM914TJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 8deb8dba-cbcf-4bdf-b6af-3671b8da5a29 61 fields · synced Oct 6, 2026
- FDA UDI b275508c-063d-444f-a4cf-77eef4f8fd91 37 fields · synced May 30, 2026