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S/FLEX BONE SYSTEM ø 3, 7 h.3 TiN c/TAS
EUDAMEDClass IIb (EU MDR)
Ref 109BSY373RT
Identity
- Trade Name
- S/FLEX BONE SYSTEM ø 3,7 h.3 TiN c/TAS EUDAMED
- Device Name
- ATTACCHI DIRETTI IN TITANIO EUDAMED
- Model / Reference
- 109BSY373RT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224075167 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
S/FLEX BONE SYSTEM ø 3, 7 h.3 TiN c/TAS 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 7267b1aa-3656-4166-8156-44e0b0fa6797 61 fields · synced Oct 7, 2026