Identity
- Trade Name
- SPEEDYBELL & INTRODUTTORE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDSPEEDYBELL & INTRODUTTORE EUDAMED
- Model / Reference
- SBTR1310EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860003104 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860003104 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 & 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 5a0983ee-7198-4aca-88ec-ab0954739beb 61 fields · synced Jul 11, 2026
- EUDAMED 60cb8d7e-5c61-4b48-b331-77e19f5b3544 61 fields · synced May 18, 2026