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Introduttore
EUDAMEDClass IIa (EU MDR)
Ref STREB1415EC-MOSRef STR1707ECRef TRC1820CRef TR2111.6ECRef STR1907ECRef STRC1415CRef STR1407ECRef STR2015ECRef TR2007ECRef STR1607ECRef TR1607ECRef STR1702ECRef TR2020EC
Identity
- Trade Name
- INTRODUTTORE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- STREB1415EC-MOS EUDAMEDSTR1707EC EUDAMEDTRC1820C EUDAMEDTR2111.6EC EUDAMEDSTR1907EC EUDAMEDSTRC1415C EUDAMEDSTR1407EC EUDAMEDSTR2015EC EUDAMEDTR2007EC EUDAMEDSTR1607EC EUDAMEDTR1607EC EUDAMEDSTR1702EC EUDAMEDTR2020EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860025984 EUDAMED08033860010317 EUDAMED08033860020682 EUDAMED08033860028329 EUDAMED08033860028428 EUDAMED08033860030537 EUDAMED08033860016692 EUDAMED08033860026479 EUDAMED08033860016074 EUDAMED08033860012533 EUDAMED08033860016982 EUDAMED08033860017088 EUDAMED08033860015251 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
Introduttore 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
- 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 (13)
- EUDAMED 2056e216-885f-47d9-8340-1359f8c76d70 61 fields · synced Sep 18, 2026
- EUDAMED c9bbd503-538a-4f7a-a39c-99a11aa69085 61 fields · synced May 16, 2026
- EUDAMED 54c6b431-ea9a-4ff6-8d74-4d73e6e2357d 61 fields · synced May 17, 2026
- EUDAMED 87cbde40-f2ed-4a69-a4d7-74bf3f3e5f99 61 fields · synced May 17, 2026
- EUDAMED 19d7f9f6-2e8f-4d7d-be34-7129a2007e09 61 fields · synced May 17, 2026
- EUDAMED 85fead20-e6c5-403e-b742-23f7e9d73eae 61 fields · synced May 18, 2026
- EUDAMED 0bfc6c95-1228-45ae-9ce9-635346729c20 61 fields · synced May 18, 2026
- EUDAMED 25c77c25-9753-401e-833b-69c309c71825 61 fields · synced May 18, 2026
- EUDAMED 6d4f246b-2e24-4713-b86a-e48bfd0d76bf 61 fields · synced May 18, 2026
- EUDAMED 33baecab-86f5-4137-a5e7-4d7b1367728c 61 fields · synced May 18, 2026
- EUDAMED 60ab0caf-b309-4cd7-8656-51c18cdaa131 61 fields · synced May 18, 2026
- EUDAMED 457e5b3a-1765-4ce9-acef-3496880ce6fb 61 fields · synced May 19, 2026
- EUDAMED b6c7d294-df97-4d4a-bd27-6b27c75f1549 61 fields · synced May 19, 2026