Identity
- Trade Name
- StoneSmart™ EUDAMED
- Device Name
- StoneSmart Connect Console EUDAMED
- Model / Reference
- M006793000D0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00191506021795 EUDAMED
- Basic UDI-DI
- 01915060000000000000581NK EUDAMED
- EMDN Code
- Z12020780 GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Rigid endoscope obturator
StoneSmart™ by Boston Scientific — 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 | 01915060000000000000581NK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (1)
- EUDAMED 582ca420-72f8-4c55-9650-6702c9389b86 61 fields · synced Jun 18, 2026