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Ezi-Crown
EUDAMEDClass IIa (EU MDR)
Ref GB2021OC006(092021)Model Ezi-Crown LC(A1, A2, A3), 703-1 Ezi-Crown A1, 703-2 Ezi-Crown A2, 703-3 Ezi-Crown A3
Identity
- Trade Name
- Ezi-Crown EUDAMED
- Device Name
- Ezi-Crown EUDAMED
- Model / Reference
- Ezi-Crown LC(A1, A2, A3), 703-1 Ezi-Crown A1, 703-2 Ezi-Crown A2, 703-3 Ezi-Crown A3 EUDAMEDGB2021OC006(092021) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809518341177 EUDAMED
- Basic UDI-DI
- B-08809518341177 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Category: Dental appliance fabrication material, resin
Ezi-Crown by MEDICLUS Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08809518341177 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEDICLUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000022584
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 97f94ad2-5ed1-486f-acc1-34435e15d49d 61 fields · synced Jul 9, 2026