Identity
- Trade Name
- HIP COIL N.11 EUDAMED
- Device Name
- MRI system, accessory Risk Class I EUDAMED
- Model / Reference
- 130000028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454379 EUDAMED
- Basic UDI-DI
- 805630445ESA.MR0000006.QB EUDAMED
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Hip Coil N.11 by Esaote S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 805630445ESA.MR0000006.QB | Class I | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (1)
- EUDAMED 9dab5d35-6b25-4222-b351-e741d44bebcf 61 fields · synced Jun 19, 2026