Identity
- Trade Name
- INTRODUTTORE EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDINTRODUTTORE EUDAMEDAghi per biopsia / Biopsy needles FDA UDI
- Model / Reference
- STR1410EC EUDAMEDINTRODUCER FDA UDI
- Description
- Aghi per biopsia / Biopsy needles FDA UDI
Identifiers
- Catalog Number
- STR1410EC FDA UDI
- Primary DI / UDI-DI
- 08033860016883 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860016883 EUDAMED
- FDA Product Code
- MJG FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 14 Gauge FDA UDI
Category: Diskectomy system, percutaneous, automatic
Introduttore by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
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- 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| 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 |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 7675fde0-4e89-4be3-95aa-11b8e6c4431a 61 fields · synced Jul 25, 2026
- EUDAMED 8695d9a4-8c8b-4a7d-af96-56c793b4bc93 61 fields · synced May 19, 2026
- FDA UDI 1ee7c059-fd3b-4605-a3da-cb1701ff89cd 36 fields · synced May 30, 2026