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Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BPX 15
Identity
- Trade Name
- Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) EUDAMEDEndorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-70682 for box of 5 FDA UDI
- Model / Reference
- BPX 15 EUDAMEDFDA UDI
- Description
- Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-70682 for box of 5 FDA UDI
Identifiers
- Catalog Number
- BPX 15 FDA UDI
- Primary DI / UDI-DI
- 10850011472146 EUDAMED00850011472149 FDA UDI
- Basic UDI-DI
- B-10850011472146 EUDAMED
- 510(k) Number
- K901888 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z1105018002 MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS 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
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: MRI system coil, radio-frequency
Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) by Dxtx Medical Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10850011472146 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DxTx Medical, Inc.
- EUDAMED SRN
- US-MF-000026795
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (2)
- EUDAMED cccb0cd8-e0f0-4033-a57a-617d483c1cef 61 fields · synced Jun 18, 2026
- FDA UDI 0cae8e00-2a6d-40ae-9196-ca9d57348f38 35 fields · synced May 30, 2026