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Gamma
EUDAMEDClass IIa (EU MDR)
Ref GM2007ECRef GM2211ECRef GM2113ECRef GM2115EC-YRef GM2205ECRef GM2035ECRef GM2018ECRef GM2010EC-YRef GM2020EC-YRef GMRA2010ECRef GM2215ERef GM2009ERef GM2012EC-YRef GM2225ECRef GM2015EC-YRef GM2218ECRef GM2209ERef GM1910ECRef GMRA2509EC
Identity
- Trade Name
- GAMMA EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDGAMMA EUDAMED
- Model / Reference
- GM2007EC EUDAMEDGM2211EC EUDAMEDGM2113EC EUDAMEDGM2115EC-Y EUDAMEDGM2205EC EUDAMEDGM2035EC EUDAMEDGM2018EC EUDAMEDGM2010EC-Y EUDAMEDGM2020EC-Y EUDAMEDGMRA2010EC EUDAMEDGM2215E EUDAMEDGM2009E EUDAMEDGM2012EC-Y EUDAMEDGM2225EC EUDAMEDGM2015EC-Y EUDAMEDGM2218EC EUDAMEDGM2209E EUDAMEDGM1910EC EUDAMEDGMRA2509EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860030674 EUDAMED08033860006990 EUDAMED08033860011093 EUDAMED08033860036348 EUDAMED08033860030650 EUDAMED08033860021047 EUDAMED08033860008031 EUDAMED08033860015312 EUDAMED08033860018146 EUDAMED08033860010638 EUDAMED08033860011611 EUDAMED08033860008819 EUDAMED08033860036379 EUDAMED08033860003425 EUDAMED08033860038014 EUDAMED08033860015787 EUDAMED08033860005771 EUDAMED08033860022600 EUDAMED08033860028848 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860036348 EUDAMEDB-08033860015312 EUDAMEDB-08033860018146 EUDAMEDB-08033860036379 EUDAMEDB-08033860038014 EUDAMEDB-08033860022600 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
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Also classified as Diskectomy system, percutaneous, automatic.
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- 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 | 8033860BIOEFT01U5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT01U5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (20)
- EUDAMED 18cdf709-4452-4c29-aa15-6db409458f2d 61 fields · synced Jul 31, 2026
- EUDAMED 19593f99-ef7a-4601-92aa-a940ab8d4d80 61 fields · synced May 11, 2026
- EUDAMED 25b1e1e2-4779-404d-aef3-837066f7d457 61 fields · synced May 16, 2026
- EUDAMED 2f7fa811-e16f-4e1c-8939-8dd370fec5ae 61 fields · synced May 17, 2026
- EUDAMED 89c1b6dd-ee6b-4692-ba5d-ecfca6bb2997 61 fields · synced May 17, 2026
- EUDAMED 130bf713-dd53-4af2-9b2d-248211aacaf1 61 fields · synced May 17, 2026
- EUDAMED b0a740e8-4092-40af-8927-778083b373c3 61 fields · synced May 17, 2026
- EUDAMED 70c3b43f-e6bb-4253-9e54-cc04ee1ba984 61 fields · synced May 17, 2026
- EUDAMED c7d09e08-9027-4d0f-a5ef-01b23aed8a28 61 fields · synced May 17, 2026
- EUDAMED 9228e3a4-6238-4a7e-8b43-c4e7217659b3 61 fields · synced May 18, 2026
- EUDAMED fe42fa67-e2cb-47d5-a592-a21447be728b 61 fields · synced May 18, 2026
- EUDAMED 55b5fd26-b5f6-4162-8f98-6a42067fe5bb 61 fields · synced May 18, 2026
- EUDAMED 67492b6b-dae9-4510-b5de-496492008a54 61 fields · synced May 18, 2026
- EUDAMED 4279c25a-deb4-4ce8-8acc-de88d47e4bb1 61 fields · synced May 18, 2026
- EUDAMED d373fcc2-2ba2-48df-94d4-74c707a3e865 61 fields · synced May 18, 2026
- EUDAMED b1a9206c-8cb3-49cc-8d38-45d85f895999 61 fields · synced May 18, 2026
- EUDAMED cd4b5645-38dc-4fe5-b3e6-f2deb8771497 61 fields · synced May 18, 2026
- EUDAMED 12b0abcf-dab9-4510-8aa1-6d33f09bc682 61 fields · synced May 19, 2026
- EUDAMED db6db910-2d32-497e-a2f4-a8a76c3bac71 61 fields · synced May 19, 2026
- EUDAMED 49c6e460-ad53-429f-b123-8929016b83c2 61 fields · synced Jul 10, 2026