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Enthes
EUDAMEDClass I (EU MDR)
Ref 320830_EModel 320740, 320750, 320750RX, 320830_E, 320832, 320834, 320760RX, 320760, 320610R
Identity
- Trade Name
- ENTHES EUDAMED
- Device Name
- AGILE, BRERA, ENTHES, INTHES, ITALA, SISTY EUDAMED
- Model / Reference
- 320740, 320750, 320750RX, 320830_E, 320832, 320834, 320760RX, 320760, 320610R EUDAMED320830_E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058302600215 EUDAMED
- Basic UDI-DI
- 805830260BARMEC66 EUDAMED
- Direct Marketing DI
- 08058302600215 EUDAMED
- EMDN Code
- V08050101 GENERIC USE STRETCHERS 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
Enthes by Malvestio Spa — 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 | 805830260BARMEC66 | Class I | Active |
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Manufacturer
- Manufacturer
- Malvestio Spa
- EUDAMED SRN
- IT-MF-000013307
Sources (1)
- EUDAMED a13ad751-6ccb-4c25-a3f1-dc7069085232 61 fields · synced Jul 9, 2026