Identity
- Trade Name
- OUTLINK2 EUDAMED
- Model / Reference
- DENTAL IMPLANT EUDAMEDE2-ZT-500-085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D7701064803 EUDAMED
- Basic UDI-DI
- B-+D7701064803 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Outlink2 by Sweden & Martina S.p.a. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+D7701064803 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sweden & Martina S.p.a.
- EUDAMED SRN
- IT-MF-000007391
Sources (1)
- EUDAMED 7bc3966a-86e9-4d55-b3d4-f3985e13ec00 61 fields · synced Jun 18, 2026