Identity
- Trade Name
- Dental Zirconia Material EUDAMED
- Device Name
- INNI-CERA EUDAMEDNNI-CERA EUDAMED
- Model / Reference
- BCM-W500 EUDAMEDBCM-W1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08801234500012 EUDAMEDD-0880123450002SY EUDAMED
- Basic UDI-DI
- B-08801234500012 EUDAMEDB-0880123450002SY EUDAMED
- EMDN Code
- Q010305 SURGICAL DENTISTRY CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Zirconia Material by DentMedi Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08801234500012 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DentMedi Co., Ltd
- EUDAMED SRN
- KR-MF-000032822
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED fbb38f1f-fef4-482b-8538-89061d5e0ca4 61 fields · synced Aug 3, 2026
- EUDAMED 4a30fa9f-3f05-4b3f-9bea-34cd87b4a25e 61 fields · synced May 18, 2026