Identity
- Trade Name
- SPHERO FLEX PITT EASY ø 4 h.4 RIV.TiN EUDAMED
- Device Name
- ATTACCHI DIRETTI IN TITANIO EUDAMED
- Model / Reference
- 109PE44R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224010076 EUDAMED
- Basic UDI-DI
- 805804571ADTK5 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER 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
SPHERO FLEX PITT EASY ø 4 h.4 RIV.TiN by Rhein 83 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 | 805804571ADTK5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (1)
- EUDAMED f2ce6fd2-1951-4e6d-abb7-b11221af75c2 61 fields · synced Sep 17, 2026