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3.0T Ingenia Endorectal Coil Interface Device (eCoil®)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4598-001-13812Model 3043032
Identity
- Trade Name
- 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) EUDAMED3.0T Ingenia Endorectal Coil Interface Device (eCoil®) - Philips FDA UDI
- Model / Reference
- 3043032 EUDAMED4598-001-13812 EUDAMEDFDA UDI
- Description
- 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) - Philips FDA UDI
Identifiers
- Catalog Number
- 4598-001-13812 FDA UDI
- Primary DI / UDI-DI
- 00850011472095 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850011472459800113812HF EUDAMED
- Direct Marketing DI
- 00850011472095 EUDAMED
- 510(k) Number
- K063342 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- MRI system coil, radio-frequency 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
Yes
FDA UDI
MR Conditional FDA UDI
3.0T Ingenia Endorectal Coil Interface Device (eCoil®) by Dxtx Medical Inc — Class I — 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 | 0850011472459800113812HF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 6cf38657-b25e-4317-a5cd-0ccb3c7af3f7 61 fields · synced Jul 16, 2026
- FDA UDI a39233df-116b-44d6-95b0-54d8fe46598c 35 fields · synced May 29, 2026