Identity
- Trade Name
- OverStitch NXT™ EUDAMED
- Device Name
- OverStitch ESS EUDAMED
- Model / Reference
- M00505420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00191506049096 EUDAMED
- Basic UDI-DI
- 01915060000000000000587NX EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Tissue morcellation system handpiece, line-powered
OverStitch NXT™ by Boston Scientific — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue morcellation system handpiece, line-powered.
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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 | 01915060000000000000587NX | 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 f2b130b9-473f-4899-afcd-e1c1b78aa3ff 61 fields · synced May 30, 2026