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Ena Matrix
EUDAMEDClass I (EU MDR)
Ref EM35Ref EMK3Ref EMKCRef EMK10N-DRef EMK1NRef EMK3N
Identity
- Trade Name
- ENA MATRIX EUDAMED
- Device Name
- ENA MATRIX EUDAMED
- Model / Reference
- EM35 EUDAMEDEMK3 EUDAMEDEMKC EUDAMEDEMK10N-D EUDAMEDEMK1N EUDAMEDEMK3N EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICEM351 EUDAMEDEMICEMK31 EUDAMEDEMICEMKC1 EUDAMEDEMICEMK10ND1 EUDAMEDEMICEMK1N1 EUDAMEDEMICEMK3N1 EUDAMED
- Basic UDI-DI
- ++EMICFAM1HVM 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
EUDAMEDEUDAMED
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 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 | ++EMICFAM1HVM | Class I | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (6)
- EUDAMED ba973923-f640-472f-9837-33e4e37bec74 61 fields · synced Aug 2, 2026
- EUDAMED 4f119603-2a0e-44d2-9ebb-276ae41b60e8 61 fields · synced Jul 13, 2026
- EUDAMED 2768e25a-1fb0-4c8f-9ef4-ffa19727d4d0 61 fields · synced Jul 21, 2026
- EUDAMED 18707940-de3c-442a-a629-78b79ba18153 61 fields · synced Jul 26, 2026
- EUDAMED 3486b1b8-592b-43c8-9ac2-0da630fc7fe5 61 fields · synced Jul 29, 2026
- EUDAMED a9ef3cad-87d2-4edd-8537-811c8c278a20 61 fields · synced Aug 2, 2026