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Fully Remove
EUDAMEDClass IIa (EU MDR)
Ref FU1515CRef FU1315CRef FUEC0710Ref FUEC1110Ref FUEC1310CRef FU1520Ref FUEC0810CRef FUEC1415Ref FUEC1315CRef FU1310CRef FUEC1306C
Identity
- Trade Name
- FULLY REMOVE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- FU1515C EUDAMEDFU1315C EUDAMEDFUEC0710 EUDAMEDFUEC1110 EUDAMEDFUEC1310C EUDAMEDFU1520 EUDAMEDFUEC0810C EUDAMEDFUEC1415 EUDAMEDFUEC1315C EUDAMEDFU1310C EUDAMEDFUEC1306C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860018504 EUDAMED08033860014735 EUDAMED08033860000943 EUDAMED08033860012137 EUDAMED08033860018122 EUDAMED08033860016173 EUDAMED08033860018009 EUDAMED08033860001216 EUDAMED08033860013806 EUDAMED08033860015152 EUDAMED08033860022068 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A01020201 ILIAC-STERNAL BIOPSY 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
Fully Remove by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (11)
- EUDAMED bf1b2417-83dc-47db-9d79-627f3cfbfbda 61 fields · synced Aug 2, 2026
- EUDAMED 9b44cab7-92a6-466e-9e47-6435409f8ee2 61 fields · synced May 16, 2026
- EUDAMED 98c61d88-9972-451f-9107-8835630abd1f 61 fields · synced May 16, 2026
- EUDAMED 071cf5f2-b2fd-4210-a7af-e4725e9fd76e 61 fields · synced May 16, 2026
- EUDAMED 9390ee47-92a2-4862-8943-34f59ac499e5 61 fields · synced May 16, 2026
- EUDAMED 4e32e4d9-f8b1-4d93-a5bb-025b5cff58f6 61 fields · synced May 17, 2026
- EUDAMED c19627ec-f4b4-4c0a-93bb-4cde66fef3d5 61 fields · synced May 17, 2026
- EUDAMED 3059bcd3-4a42-4a95-87b0-fafaca305341 61 fields · synced May 17, 2026
- EUDAMED 866bea8d-9af7-483d-9553-458888c40807 61 fields · synced May 17, 2026
- EUDAMED 7e57014f-c9c4-462d-9c3b-3d1f2515d7ec 61 fields · synced May 18, 2026
- EUDAMED 3f1548a1-27e9-44b5-a565-55d5c20e8e3a 61 fields · synced May 18, 2026