Identity
- Trade Name
- ESTER ONE SHOT EUDAMED
- Device Name
- ESTER ONE SHOT EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- GUN1820ECT-OS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860038311 EUDAMED
- Basic UDI-DI
- B-08033860038311 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 One Shot 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-08033860038311 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860038311 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 2941461a-c390-4f90-aa4d-05a7215e5899 61 fields · synced Jul 26, 2026
- EUDAMED 8690c0ae-36e0-445f-b193-1daf4a62cd9c 61 fields · synced May 19, 2026