Identity
- Trade Name
- ESTER EUDAMED
- Device Name
- ESTER EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- GUN1815EC10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860007959 EUDAMED
- Basic UDI-DI
- B-08033860007959 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
Ester 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-08033860007959 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860007959 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED c8008235-277e-4810-af25-85b91739fba6 61 fields · synced Sep 17, 2026
- EUDAMED 29cb823b-3eec-4788-a6ea-b96d1ebba57f 61 fields · synced May 19, 2026