← Back to catalogue
Franseen
EUDAMEDClass IIa (EU MDR)
Ref FR2112ECRef FR2215ECRef FR2109ECRef FR1610Ref FR2015Ref FR2110ECRef FR2220ECRef FR2210
Identity
- Trade Name
- FRANSEEN EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- FR2112EC EUDAMEDFR2215EC EUDAMEDFR2109EC EUDAMEDFR1610 EUDAMEDFR2015 EUDAMEDFR2110EC EUDAMEDFR2220EC EUDAMEDFR2210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860029852 EUDAMED08033860007072 EUDAMED08033860029845 EUDAMED08033860010515 EUDAMED08033860014391 EUDAMED08033860029838 EUDAMED08033860014353 EUDAMED08033860008536 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A01020102 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
Category: Diskectomy system, percutaneous, automatic
Franseen by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- 0ME2320 — Biomedical S.r.l. · Class IIa
- 0ME1810 — Biomedical S.r.l. · Class IIa
- CER-SUB-825 — RANFAC CORP. · Class IIa
- CytoCut — M.D.L. S.R.L. · Class IIa
- Fine Needle Aspiration Biopsy Needle — Canyon Medical Inc. · Class IIa
- Fine Needle Aspiration Biopsy Needle — Canyon Medical Inc. · Class IIa
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 | 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 (8)
- EUDAMED 9e132f26-7679-453b-bfd2-3034ee342bd4 61 fields · synced Aug 3, 2026
- EUDAMED 1ca26252-f446-469b-b952-b2273e0f053c 61 fields · synced May 17, 2026
- EUDAMED db58a366-5ff5-4908-aeb2-3a24c16392a3 61 fields · synced May 18, 2026
- EUDAMED 53ecfe88-b610-4eab-a48e-b4f4d2dde848 61 fields · synced May 18, 2026
- EUDAMED 108e49f1-c9ac-4c07-9e01-de3bece26ffb 61 fields · synced May 18, 2026
- EUDAMED 5e5dcb1b-a8a6-4752-ae72-b0a4a0f91496 61 fields · synced May 18, 2026
- EUDAMED f67dbea8-69d1-4b5b-9348-d5308d0a2658 61 fields · synced May 18, 2026
- EUDAMED 1fad1be3-b006-4b81-9f52-43f1a79f9180 61 fields · synced May 19, 2026