Identity
- Trade Name
- NobelReplace® S TiUnite® NP 4.3x11.5mm EUDAMED
- Device Name
- Tapered implants EUDAMED
- Model / Reference
- 302403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332747223248 EUDAMED
- Basic UDI-DI
- 733274700000012875 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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
NobelReplace® S TiUnite® NP 4.3x11.5mm by Nobel Biocare AB — 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 | 733274700000012875 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (1)
- EUDAMED 087fc7a4-0fcb-4eec-86c8-5e2789276514 61 fields · synced Jun 17, 2026