Identity
- Trade Name
- Smart-Port EUDAMED
- Device Name
- Transportable dental treatment units EUDAMED
- Model / Reference
- D-13000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640185020061 EUDAMED
- Basic UDI-DI
- 76401850200001LS EUDAMED
- Direct Marketing DI
- 07640185020061 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Dental delivery system
Smart-Port by BPR Swiss GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 76401850200001LS | Class IIa | Active |
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Manufacturer
- Manufacturer
- BPR Swiss GmbH
- EUDAMED SRN
- CH-MF-000018810
- Authorised Representative
- Klaus Seiler DE-AR-000016462
Sources (1)
- EUDAMED 7d3112fd-9ea4-448f-b420-99d760b61730 61 fields · synced Jul 13, 2026