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1 Ch Left Coil Element Sen 1.5t
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 300006547291
Identity
- Trade Name
- 1 CH LEFT COIL ELEMENT SEN 1.5T EUDAMEDDUNLEE SENTINELLE FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Siemens Breast Coil PMS EUDAMED1Ch Left Coil Element Sen 1.5T FDA UDI
- Model / Reference
- 300006547291 EUDAMED1Ch Left Coil Element Sen 1.5T FDA UDI
- Description
- 1Ch Left Coil Element Sen 1.5T FDA UDI
Identifiers
- Catalog Number
- 300006547291 FDA UDI
- Primary DI / UDI-DI
- 00884838109605 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM909TR EUDAMED
- Direct Marketing DI
- 00884838109605 EUDAMED
- 510(k) Number
- K112112 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
1 Ch Left Coil Element Sen 1.5t by Philips Medical Systems Nederland B.V. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0884838BM909TR | 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 262b7292-bd35-4935-ae9f-877faae24c17 61 fields · synced Oct 6, 2026
- FDA UDI 55fec42f-154c-4048-a7c5-fbb3a5545b39 37 fields · synced May 30, 2026