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SPHERO FLEX SwissPlus ø 3, 7 AT h1 TiN cT
EUDAMEDClass IIb (EU MDR)
Ref 109SWP37AT1RT
Identity
- Trade Name
- SPHERO FLEX SwissPlus ø 3,7 AT h1 TiN cT EUDAMED
- Device Name
- ATTACCHI DIRETTI IN TITANIO EUDAMED
- Model / Reference
- 109SWP37AT1RT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224021553 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 SwissPlus ø 3, 7 AT h1 TiN cT 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 d9b6ef7a-0ede-4144-981f-b042ccc18ed2 61 fields · synced Oct 7, 2026