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Ena Matrix /Ena Wedge Plastic / Plastic Matrix/Wedge
EUDAMEDClass I (EU MDR)
Ref EMWM-1Model Plastic Matrix/Wedge
Identity
- Device Name
- Ena Matrix /Ena Wedge Plastic / Plastic Matrix/Wedge EUDAMED
- Model / Reference
- Plastic Matrix/Wedge EUDAMEDEMWM-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICEMWM11 EUDAMED
- Basic UDI-DI
- ++EMICFAM1HPL3G EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY 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
Ena Matrix /Ena Wedge Plastic / Plastic Matrix/Wedge by Micerium S.p.A. — 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 | ++EMICFAM1HPL3G | Class I | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (1)
- EUDAMED be75d0d6-a291-431c-b973-c269f7d64949 61 fields · synced Aug 4, 2026