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Flat Tip Osteotome For Shelta
EUDAMEDClass I (EU MDR)
Ref FLAT TIP OSTEOTOME FOR SHELTAModel 0006Ref SH-OS-500-100-PPRef SH-OS-425-115-PPRef SH-OS-380-100-PPRef SH-M-425-085 Model DENTAL IMPLANT Ref SH-OS-425-130-PPRef SH-OS-500-130-PPRef SH-OS-425-100-PP
Identity
- Trade Name
- FLAT TIP OSTEOTOME FOR SHELTA EUDAMEDSHELTA EUDAMED
- Model / Reference
- 0006 EUDAMEDFLAT TIP OSTEOTOME FOR SHELTA EUDAMEDSH-OS-500-100-PP EUDAMEDSH-OS-425-115-PP EUDAMEDSH-OS-380-100-PP EUDAMEDDENTAL IMPLANT EUDAMEDSH-M-425-085 EUDAMEDSH-OS-425-130-PP EUDAMEDSH-OS-500-130-PP EUDAMEDSH-OS-425-100-PP EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D7701237093 EUDAMED+D7701237083 EUDAMED+D7701237053 EUDAMED+D7701237003 EUDAMED+D7701237013 EUDAMED+D7701568533 EUDAMED+D7701237063 EUDAMED+D7701237103 EUDAMED+D7701237043 EUDAMED
- Basic UDI-DI
- ++D7700006YM EUDAMEDB-+D7701568533 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMEDP01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMEDEUDAMED
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Flat Tip Osteotome For Shelta by Sweden & Martina S.p.a. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D7700006YM | Class I | Active |
| EUDAMED | European Union | CE/MDD | ++D7700006YM | Class I | Active |
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Manufacturer
- Manufacturer
- Sweden & Martina S.p.a.
- EUDAMED SRN
- IT-MF-000007391
Sources (9)
- EUDAMED 0990f58c-5118-4aca-88c0-b59a62c64697 61 fields · synced Jul 28, 2026
- EUDAMED 4da41568-a649-4571-a366-2fd90e2c31f7 61 fields · synced May 16, 2026
- EUDAMED 63955919-123c-4048-840e-d43e37d19ddc 61 fields · synced May 17, 2026
- EUDAMED 5d209220-0985-493d-9c89-bb4d00a74c2f 61 fields · synced May 17, 2026
- EUDAMED 625cebbd-67f2-42bd-ba7c-4ffbd84dcac1 61 fields · synced May 17, 2026
- EUDAMED e5eb7d69-4c90-451f-9b89-e3e654b44cb9 61 fields · synced May 18, 2026
- EUDAMED 05e1482e-8cdc-42e2-a93c-6c2c86480760 61 fields · synced May 18, 2026
- EUDAMED 2706c36f-1446-48d9-b2ed-c7e8e0de2b9b 61 fields · synced May 19, 2026
- EUDAMED dbefe919-8cfa-4d93-92e1-d4b2e56a1a63 61 fields · synced May 19, 2026