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Implant prosthetic components
EUDAMEDClass IIb (EU MDR)
Ref KAPT 5363Model Implant prosthetic components
Identity
- Device Name
- Implant prosthetic components EUDAMED
- Model / Reference
- Implant prosthetic components EUDAMEDKAPT 5363 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059571004216 EUDAMED
- Basic UDI-DI
- 805957100PROTESICL.2MS EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Implant prosthetic components by ZIACOM ITS S.r.l. — Class IIb — 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 | 805957100PROTESICL.2MS | Class IIb | Active |
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Manufacturer
- Manufacturer
- ZIACOM ITS S.r.l.
- EUDAMED SRN
- IT-MF-000028897
Sources (1)
- EUDAMED 3bbf0f8d-4492-463c-8bd0-b069d4ae98e9 61 fields · synced Jul 22, 2026