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Top S4 115
EUDAMEDClass IIa (EU MDR)
Ref TOP S4 115Model Dental Instruments Class IIa, Drill Stop
Identity
- Model / Reference
- Dental Instruments Class IIa, Drill Stop EUDAMEDTOP S4 115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436560959687 EUDAMED
- Basic UDI-DI
- 0843656095TOPE8W EUDAMED
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
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
Top S4 115 by Phibo Dental Solutions S.L. — Class IIa — 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 | 0843656095TOPE8W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Phibo Dental Solutions S.L.
- EUDAMED SRN
- ES-MF-000024464
Sources (1)
- EUDAMED 1138e328-1783-41ba-9682-8e172c0a93ff 61 fields · synced Jun 18, 2026