Identity
- Trade Name
- ZENEX PLUS Fixture Set EUDAMED
- Device Name
- ZENEX PLUS Fixture Set (Fixture + Cover Screw) EUDAMED
- Model / Reference
- ZPTW5515S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070229989 EUDAMED
- Basic UDI-DI
- B-08800070229989 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
ZENEX PLUS Fixture Set by Izenimplant Co., Ltd. — Class IIb — 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-08800070229989 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 14174bfe-cfe0-4c70-b47e-ff3c2121b563 61 fields · synced May 22, 2026