Identity
- Trade Name
- GAMMA EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDGAMMA EUDAMED
- Model / Reference
- GM1909EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860029371 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860029371 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Diskectomy system, percutaneous, automatic.
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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 (2)
- EUDAMED cc6e4a2d-7a1d-4931-8adb-00ead4146dc5 61 fields · synced Sep 18, 2026
- EUDAMED 3940d2d7-edcf-43e4-8d24-fb78bbf9232b 61 fields · synced May 19, 2026