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N Quadra Helical Z [Nitinol Stone Basket Helical Zero Tip]
EUDAMEDClass IIa (EU MDR)
Ref BESBN003070H3
Identity
- Trade Name
- N Quadra Helical Z [Nitinol Stone Basket Helical Zero Tip] EUDAMED
- Device Name
- Stone Baskets EUDAMED
- Model / Reference
- BESBN003070H3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905080010388 EUDAMED
- Basic UDI-DI
- 8905080BSBGN EUDAMED
- EMDN Code
- U090101 URINARY STONE RETRIEVAL BASKETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
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
N Quadra Helical Z [Nitinol Stone Basket Helical Zero Tip] by Blue Neem Medical Devices Private Limited — Class IIa — MDR — listed in EUDAMED
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 | 8905080BSBGN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Neem Medical Devices Private Limited
- EUDAMED SRN
- IN-MF-000021793
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (1)
- EUDAMED 0545084e-e3a1-4c68-ac22-79200600389e 61 fields · synced Oct 6, 2026