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Top S5 115
EUDAMEDClass IIa (EU MDR)
Ref TOP S5 115Model Dental Instruments Class IIa, Drill Stop
Identity
- Model / Reference
- Dental Instruments Class IIa, Drill Stop EUDAMEDTOP S5 115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436560959755 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 S5 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 8fc2e93d-e6e3-4782-aa6f-cd36e6176a6f 61 fields · synced Jul 10, 2026