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Xive38
EUDAMEDClass I (EU MDR)
Ref XIVE38Model Non implantable attachments, Scanbodies
Identity
- Model / Reference
- Non implantable attachments, Scanbodies EUDAMEDXIVE38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435567317841 EUDAMED
- Basic UDI-DI
- 084355673LIBRDV EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Xive38 by Phibo Dental Solutions S.L. — 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 | 084355673LIBRDV | Class I | Active |
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Manufacturer
- Manufacturer
- Phibo Dental Solutions S.L.
- EUDAMED SRN
- ES-MF-000024464
Sources (1)
- EUDAMED 4db52ca5-340b-4974-aff0-237360f5da5b 61 fields · synced Jun 18, 2026