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Reply For Shelta Implant
EUDAMEDClass I (EU MDR)
Ref SH-380-130-RPModel 0006Ref SH-600-130-RPRef SH-425-085-RPRef SH-380-115-RPRef SH-600-115-RPRef SH-500-130-RPRef SH-500-115-RP
Identity
- Trade Name
- REPLY FOR SHELTA IMPLANT EUDAMED
- Model / Reference
- 0006 EUDAMEDSH-380-130-RP EUDAMEDSH-600-130-RP EUDAMEDSH-425-085-RP EUDAMEDSH-380-115-RP EUDAMEDSH-600-115-RP EUDAMEDSH-500-130-RP EUDAMEDSH-500-115-RP EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D7701091913 EUDAMED+D7701278153 EUDAMED+D7701091933 EUDAMED+D7701091903 EUDAMED+D7701278143 EUDAMED+D7701092013 EUDAMED+D7701092003 EUDAMED
- Basic UDI-DI
- ++D7700006YM EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
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
Reply For Shelta Implant by Sweden & Martina S.p.a. — Class I — 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 | ++D7700006YM | Class I | Active |
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Manufacturer
- Manufacturer
- Sweden & Martina S.p.a.
- EUDAMED SRN
- IT-MF-000007391
Sources (7)
- EUDAMED 174588b9-0a6b-4bbd-bc5c-59faf7843ca5 61 fields · synced Aug 3, 2026
- EUDAMED 79b35a2f-9171-41e3-9fcf-b962b6bd8564 61 fields · synced May 16, 2026
- EUDAMED 073a8f0b-dc6f-4a61-ae85-82e7db5c4d72 61 fields · synced May 17, 2026
- EUDAMED 59a5a994-764d-4dcd-ac42-50f3f8935660 61 fields · synced May 17, 2026
- EUDAMED d4e17dc5-4e24-4706-9c8c-83aa8dfecc51 61 fields · synced May 18, 2026
- EUDAMED 50755f6d-38d8-4932-9a11-751d63d98dc2 61 fields · synced May 18, 2026
- EUDAMED a717b89d-fa5d-4403-9d05-46341bca71ef 61 fields · synced May 18, 2026