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Ester One Shot & Introduttore
EUDAMEDClass IIa (EU MDR)
Ref GUNTR2015EC-OSModel ESTER ONE SHOT & INTRODUTTORE
Identity
- Trade Name
- ESTER ONE SHOT & INTRODUTTORE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDGUNTR2015EC-OS EUDAMED
- Model / Reference
- GUNTR2015EC-OS EUDAMEDESTER ONE SHOT & INTRODUTTORE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860039738 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860039738 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 & Introduttore by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| 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 |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED d1dd2f67-462e-416d-b449-ab2c1bb1c14c 61 fields · synced Jul 11, 2026
- EUDAMED a65dd1f6-f432-4bec-af3b-60dcf7576a3a 61 fields · synced May 19, 2026