Identity
- Trade Name
- Eztetic® EUDAMED
- Device Name
- Non sterile powered invasive instrument EUDAMED
- Model / Reference
- CHDL2.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889024343474 EUDAMED
- Basic UDI-DI
- 844868AMJG EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Eztetic® by ZimVie US Corp LLC — Class IIa — 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 | 844868AMJG | Class IIa | Active |
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Manufacturer
- Manufacturer
- ZimVie US Corp LLC
- EUDAMED SRN
- US-MF-000048255
- Authorised Representative
- ZimVie Spain S.L.U. ES-AR-000000983
Sources (1)
- EUDAMED 4f2506bf-9a92-4c28-a07c-73780aa19d6d 61 fields · synced Jun 19, 2026