Identity
- Trade Name
- TMJ COIL 19 EUDAMEDTMJ COIL N.19 FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- MRI system, accessory Risk Class I EUDAMEDCoil for S-scan FDA UDI
- Model / Reference
- 130000006 EUDAMEDFDA UDI
- Description
- Coil for S-scan FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304452351 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.MR0000006.QB EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS 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
- Italy 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
Category: MRI system coil, radio-frequency
Tmj Coil 19 by Esaote S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 805630445ESA.MR0000006.QB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 02438a9b-de95-48f1-83ce-8798c093a5a5 61 fields · synced Jun 20, 2026
- FDA UDI 39ec3dd0-6e03-44db-8746-f84993ed04e8 33 fields · synced May 30, 2026