Identity
- Trade Name
- HEAD COIL EUDAMEDHEAD COIL N.16 EUDAMEDHEAD COIL N.16 FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- MRI system, accessory Risk Class I EUDAMEDCoil for S-scan - G-scan Brio FDA UDI
- Model / Reference
- 130000025 EUDAMED131000100 EUDAMEDFDA UDI
- Description
- Coil for S-scan - G-scan Brio FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304454560 EUDAMED08056304452719 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.MR0000006.QB EUDAMED
- 510(k) Number
- K161973 FDA UDI
- FDA Product Code
- MOS 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 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
Head Coil 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 (3)
- EUDAMED 767877ea-d097-41e6-ac98-5191f1fd75c0 61 fields · synced Jul 29, 2026
- EUDAMED 5c8929ca-f075-48d2-9343-ff5fd9695c4c 61 fields · synced May 16, 2026
- FDA UDI 36024308-487e-4f13-a1a7-159353799c88 34 fields · synced May 30, 2026