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Gamma E Prolunga
EUDAMEDClass IIa (EU MDR)
Ref GM2215ECP15Ref GM1815ECP15Ref GM2009ECP15Ref GM2210ECP15
Identity
- Trade Name
- GAMMA E PROLUNGA EUDAMEDGAMMA EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDGAMMA EUDAMEDGAMMA E PROLUNGA EUDAMED
- Model / Reference
- GM2215ECP15 EUDAMEDGM1815ECP15 EUDAMEDGM2009ECP15 EUDAMEDGM2210ECP15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860012854 EUDAMED08033860005894 EUDAMED08033860030452 EUDAMED08033860011413 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860005894 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
Gamma E Prolunga by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
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- 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/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 (6)
- EUDAMED cac80cf6-b84e-4ad0-b67b-d3181ecbf351 61 fields · synced Aug 3, 2026
- EUDAMED 9017a8d8-a295-47e2-a47f-00f016d5569a 61 fields · synced May 17, 2026
- EUDAMED d982dea3-5ef1-4221-926c-e93ed81a854d 61 fields · synced May 17, 2026
- EUDAMED 0e63ae8c-1e60-4651-a5ef-f9ca2a6fd335 61 fields · synced May 18, 2026
- EUDAMED 128fe94b-f49f-4063-acc5-543196278a75 61 fields · synced May 19, 2026
- EUDAMED cab298b0-2604-47d9-b9ac-2d798d9aacc2 61 fields · synced Aug 3, 2026