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Implant prosthetic components
EUDAMEDClass IIb (EU MDR)
Ref HAC 5532Model Implant prosthetic components
Identity
- Device Name
- Implant prosthetic components EUDAMED
- Model / Reference
- Implant prosthetic components EUDAMEDHAC 5532 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059571002144 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 0c99d515-a94d-44e8-98fb-9f4569391ae4 61 fields · synced Jul 19, 2026