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FreeMilling Abutment + Abutment Screw
EUDAMEDClass IIb (EU MDR)
Ref FMARRH60508S
Identity
- Device Name
- FreeMilling Abutment + Abutment Screw EUDAMED
- Model / Reference
- FMARRH60508S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070224311 EUDAMED
- Basic UDI-DI
- B-08800070224311 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb 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
FreeMilling Abutment + Abutment Screw 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-08800070224311 | 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 259675a2-f2e1-4a38-b80b-114bb141a797 61 fields · synced Sep 18, 2026