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Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens
EUDAMEDClass I (EU MDR)
Ref BPX 30 NG-S
Identity
- Trade Name
- Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens EUDAMED
- Device Name
- Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens EUDAMED
- Model / Reference
- BPX 30 NG-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850011472002 EUDAMED
- Basic UDI-DI
- 0850011472BPX30NG-SJ8 EUDAMED
- EMDN Code
- Z1105018002 MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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
Category: MRI system coil, radio-frequency
Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens by Dxtx Medical Inc — Class I — MDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850011472BPX30NG-SJ8 | Class I | Active |
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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 (1)
- EUDAMED d7ec6de2-e89c-46a5-ace4-b677b904636f 61 fields · synced Jun 19, 2026