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Core Biopsy Puncture Sheath V
EUDAMEDClass IIa (EU MDR)
Ref 170551-USRef 170601-USRef 170603-USRef 170533-USRef 170531-USRef 170543-USRef 170563-US
Identity
- Trade Name
- CORE BIOPSY PUNCTURE SHEATH V EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- 170551-US EUDAMED170601-US EUDAMED170603-US EUDAMED170533-US EUDAMED170531-US EUDAMED170543-US EUDAMED170563-US EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860021955 EUDAMED08033860023669 EUDAMED08033860023645 EUDAMED08033860021894 EUDAMED08033860021870 EUDAMED08033860021931 EUDAMED08033860022013 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 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
Core Biopsy Puncture Sheath V by Biopsybell Srl — Class IIa — MDR — 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
| 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 (7)
- EUDAMED d5b98885-3367-4acb-9f98-abd2ca0184d7 61 fields · synced Jul 29, 2026
- EUDAMED 6e49f634-be20-4b55-a41f-03a043c25225 61 fields · synced May 16, 2026
- EUDAMED ce46d580-217b-4a81-9eeb-9304c2b5a2a4 61 fields · synced May 18, 2026
- EUDAMED d19c9004-e4dd-46f8-8e3a-88ae5b1ef934 61 fields · synced May 18, 2026
- EUDAMED 890d9c04-54a8-479d-bfb4-6f9677489d8c 61 fields · synced May 18, 2026
- EUDAMED 4d6d02ea-4af2-430a-88d4-e1cd581f07db 61 fields · synced May 19, 2026
- EUDAMED 3d69e197-9d80-4116-a42c-a69ca6438ae9 61 fields · synced May 19, 2026