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Biosoft
EUDAMEDClass IIa (EU MDR)
Ref BSF2207CRef BSF1815C-GLPRef BSF1607CRef BSF1615CRef BSF1810C-GLPRef BSF2115CRef BSF1609CRef BSF1820C-GLPRef BSFTR1810CRef BSF1920C-GLPRef BSF2120CRef BSF2010CRef BSF1607C-GLPRef BSF1807CRef BSF1415CRef BSFTR1815CRef BSF1318CRef BSF1805CRef TRC1810CRef BSF1707C
Identity
- Trade Name
- BIOSOFT EUDAMEDBIOSOFT & INTRODUTTORE EUDAMEDINTRODUTTORE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDBIOSOFT EUDAMEDSOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC) EUDAMED
- Model / Reference
- BSF2207C EUDAMEDBSF1815C-GLP EUDAMEDBSF1607C EUDAMEDBSF1615C EUDAMEDBSF1810C-GLP EUDAMEDBSF2115C EUDAMEDBSF1609C EUDAMEDBSF1820C-GLP EUDAMEDBSFTR1810C EUDAMEDBSF1920C-GLP EUDAMEDBSF2120C EUDAMEDBSF2010C EUDAMEDBSF1607C-GLP EUDAMEDBSF1807C EUDAMEDBSF1415C EUDAMEDBSFTR1815C EUDAMEDBSF1318C EUDAMEDBSF1805C EUDAMEDTRC1810C EUDAMEDBSF1707C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860026868 EUDAMED08033860005696 EUDAMED08033860008352 EUDAMED08033860003043 EUDAMED08033860007577 EUDAMED08033860005337 EUDAMED08033860008376 EUDAMED08033860029494 EUDAMED08033860016395 EUDAMED08033860029616 EUDAMED08033860008390 EUDAMED08033860015749 EUDAMED08033860015640 EUDAMED08033860018702 EUDAMED08033860016807 EUDAMED08033860009199 EUDAMED08033860025472 EUDAMED08033860008956 EUDAMED08033860020644 EUDAMED08033860026806 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860005696 EUDAMEDB-08033860005337 EUDAMEDB-08033860007577 EUDAMEDB-08033860003043 EUDAMEDB-08033860029616 EUDAMEDB-08033860029494 EUDAMEDB-08033860015749 EUDAMED8033860BIOAFT01SR EUDAMED
- EMDN Code
- A0102010102 SHEARING BIOPSY GUNS EUDAMEDA01020102 ASPIRATION FINE NEEDLES AND KITS 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
Biosoft 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 (35)
- EUDAMED 02390f20-db84-43dd-a379-851e3d302f16 61 fields · synced Sep 17, 2026
- EUDAMED 160eaafb-026c-4d47-b652-9b34e937a322 61 fields · synced May 11, 2026
- EUDAMED 84fd8171-aacd-4327-bbba-4b19dcea586a 61 fields · synced May 16, 2026
- EUDAMED a5fd83bd-60da-40d5-84dd-4f6f33447e65 61 fields · synced May 16, 2026
- EUDAMED daa20728-db1a-456d-be4a-ff92991662b8 61 fields · synced May 16, 2026
- EUDAMED 48d34c65-1cc8-435a-8e02-929a814a5ef5 61 fields · synced May 16, 2026
- EUDAMED 85227179-86d4-4478-9c53-fde8c2620e26 61 fields · synced May 16, 2026
- EUDAMED 66c90ec1-885a-4625-aaf1-3143b019734f 61 fields · synced May 17, 2026
- EUDAMED 1ac0ee70-a5f3-4d09-9815-d1059debaffe 61 fields · synced May 17, 2026
- EUDAMED d9624c7d-9164-4b66-9f6d-5d8b78724ad3 61 fields · synced May 17, 2026
- EUDAMED b4077070-e045-4cdc-ba67-5c83349cef36 61 fields · synced May 17, 2026
- EUDAMED 312eb395-9f99-4a40-87d9-4b2a6d2e6721 61 fields · synced May 17, 2026
- EUDAMED 9c09de64-684b-4991-b907-0f58eb527d38 61 fields · synced May 17, 2026
- EUDAMED f1a88c70-41cf-4571-8a23-69749d28c35f 61 fields · synced May 17, 2026
- EUDAMED 3ec903b4-0093-4c18-8eec-4c333826a684 61 fields · synced May 17, 2026
- EUDAMED 3a2f0c8e-6030-4100-b1a6-f0d13c0b7eeb 61 fields · synced May 18, 2026
- EUDAMED b2783f11-61b7-43a0-96dd-52313f68c80f 61 fields · synced May 18, 2026
- EUDAMED 7a73b413-031c-4d1c-b266-0749ac89146e 61 fields · synced May 18, 2026
- EUDAMED deaaf005-292f-4e30-8fc6-7d1ee7bcce11 61 fields · synced May 19, 2026
- EUDAMED 0a621710-7746-492f-aff6-58618946b27b 61 fields · synced May 19, 2026
- EUDAMED f9e1fc55-2790-4163-8c0d-547e76574583 61 fields · synced May 19, 2026
- EUDAMED 22e45766-c5a4-4e80-b68d-d93eb9eb5e28 61 fields · synced May 19, 2026
- EUDAMED e9f21b54-bfc3-4bd0-8b17-4edf737b75ee 61 fields · synced May 19, 2026
- EUDAMED a47e0884-84ff-41c5-b8be-737e5f0d6950 61 fields · synced May 19, 2026
- EUDAMED 7b7c345c-e67b-4082-979a-4abd8184a8d8 61 fields · synced May 19, 2026
- EUDAMED b72d005f-2ccd-42b0-9c7c-110ede1cf648 61 fields · synced May 19, 2026
- EUDAMED 5d73f437-f253-4f9a-b472-c81425c999aa 61 fields · synced May 19, 2026
- EUDAMED 79f5fd7f-c269-41cd-8f2d-cff1e10b3b27 61 fields · synced Jun 18, 2026
- EUDAMED 04d2cdf8-4bfa-4269-aefb-04f3a260fde6 61 fields · synced Jul 8, 2026
- EUDAMED 7899eace-6103-4655-92e0-beebdd096603 61 fields · synced Jul 8, 2026
- EUDAMED d5623e4e-48bb-434d-943f-87f9a81f5478 61 fields · synced Jul 8, 2026
- EUDAMED 270cf978-e4e7-4b3a-a421-11e2491a2340 61 fields · synced Jul 11, 2026
- EUDAMED e05f13b0-5e5f-4431-b4bb-92839a46614d 61 fields · synced Jul 17, 2026
- EUDAMED 4a7404e8-b849-4368-a075-f81292fb31cc 61 fields · synced Aug 2, 2026
- EUDAMED ea224658-ed4d-4a75-aff2-4a639c13e7b6 61 fields · synced Aug 4, 2026