Identity
- Trade Name
- ORSI GUN & INTRODUTTORE EUDAMED
- Device Name
- ORSI GUN & INTRODUTTORE EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- GUNTR1815ECISO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860009458 EUDAMED
- Basic UDI-DI
- B-08033860009458 EUDAMED8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A0102010102 SHEARING BIOPSY GUNS 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
Orsi Gun & Introduttore by Biopsybell Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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 | B-08033860009458 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860009458 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 561ff209-9de7-49c6-9ac5-090480063cac 61 fields · synced Jun 19, 2026
- EUDAMED 8b8cfe8f-ecae-46c9-ad08-122ea3b09e75 61 fields · synced May 19, 2026