Identity
- Trade Name
- PHYSIO-F3 EUDAMED
- Device Name
- UNIKO PZ EUDAMED
- Model / Reference
- PHYSIO-F3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056746330392 EUDAMED
- Basic UDI-DI
- 805674633SURDEVTL EUDAMED
- Direct Marketing DI
- 08056746330392 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Dental delivery system
The UNIKO PZ medical device is a Class IIa implantable system used for the endocrine disruption of human hormones. Developed by Mariotti & C.S.R.L., this device has undergone rigorous testing and evaluation to ensure its safety and efficacy. With its sterile design and standard regulatory compliance, the UNIKO PZ is an ideal solution for medical professionals seeking to treat hormone-related disorders.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805674633SURDEVTL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mariotti & C. S.r.l.
- EUDAMED SRN
- IT-MF-000035061
Sources (2)
- EUDAMED 2f0b59d3-fc08-4ffc-a912-709afc58640a 61 fields · synced Jul 22, 2026
- EUDAMED 6e58b77d-036c-46d5-93f9-153ed599964c 61 fields · synced Jun 18, 2026