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Speedybell Doppia Corsa & Introduttore
EUDAMEDClass IIa (EU MDR)
Ref SBDTRRN1610EC
Identity
- Trade Name
- SPEEDYBELL DOPPIA CORSA & INTRODUTTORE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDSPEEDYBELL DOPPIA CORSA & INTRODUTTORE EUDAMED
- Model / Reference
- SBDTRRN1610EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860010591 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860010591 EUDAMED
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Speedybell Doppia Corsa & Introduttore by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT01U5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT01U5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 1c21f626-6058-46c8-bed3-c99d204a089a 61 fields · synced Jun 19, 2026
- EUDAMED a2cf9187-c4e0-44c6-95af-b608c3cd1ed7 61 fields · synced Jun 19, 2026