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Siemens 1.5T Endo Interface (eCoil®)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7582385
Identity
- Trade Name
- Siemens 1.5T Endo Interface (eCoil®) EUDAMEDDxTx Medical 1.5T eCoil Imaging Device (for Siemens) FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Siemens 1.5T Endo Interface (eCoil®) EUDAMEDEcoil ID - FID SYM FRU FDA UDI
- Model / Reference
- 7582385 EUDAMEDFID SYM FRU FDA UDI
- Description
- Ecoil ID - FID SYM FRU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011472217 EUDAMEDFDA UDI
- Basic UDI-DI
- 085001147207582385VT EUDAMED
- Direct Marketing DI
- 00850011472217 EUDAMED
- 510(k) Number
- K971380 FDA UDI
- FDA Product Code
- LNH 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
Siemens 1.5T Endo Interface (eCoil®) by Dxtx Medical Inc — Class I — 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 | 085001147207582385VT | 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 e2c260a9-5eef-4fe0-a995-3864dd9aeb81 61 fields · synced Jul 9, 2026
- FDA UDI 74f583bf-533d-4ff7-bb78-233d9f48c6ff 34 fields · synced May 30, 2026