Identity
- Trade Name
- GAMMA EUDAMED
- Device Name
- GAMMA EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- GM2215EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860003463 EUDAMED
- Basic UDI-DI
- B-08033860003463 EUDAMED8033860BIOEFT01U5 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 by Biopsybell Srl — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860003463 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860003463 | 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 93f67803-6145-4840-83de-b256ed69d561 61 fields · synced Jun 19, 2026
- EUDAMED a9117ffe-62cc-45c0-bd00-2d6eb5a477ee 61 fields · synced May 19, 2026