Identity
- Trade Name
- Sedia amagnetica MR safe EUDAMED
- Device Name
- Sedia amagnetica MR Safe EUDAMED
- Model / Reference
- SRM 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053307710150 EUDAMED
- Basic UDI-DI
- 805330771107A5 EUDAMED
- Direct Marketing DI
- 08053307710150 EUDAMED
- EMDN Code
- Z11059099 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER 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
Sedia amagnetica MR safe by Enclara Medical s.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 805330771107A5 | Class I | Active |
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Manufacturer
- Manufacturer
- Enclara Medical s.r.l.
- EUDAMED SRN
- IT-MF-000013110
Sources (1)
- EUDAMED cc384ebb-08a4-445e-9017-42c45f144320 61 fields · synced Aug 1, 2026