Ester One Shot & Introduttore
by Biopsybell SRL Italy EUDAMED
Ref GUNTR1415ECT-OS
EMDN A0102010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIT349638 | Date10 Feb 2026 | StatusWithdrawn |
| European Union | CE/MDD | Number8033860BIOEFT01U5 | Date20 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDD, CE/MDR Active
Certificates
- IT349638 Withdrawn
Quality assurance EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 10 Feb 2026
- Expires
- 9 Feb 2030
- Reason
- Other
Specification
- Device Name
- Needles for Biopsy or ExplantSoft Tissues Biopsy Needles (Semiautomatic and Automatic)
- Model / Reference
- GUNTR1415ECT-OS
- Primary DI / UDI-DI
- 08033860038472
- Basic UDI-DI
- 8033860BIOEFT01U5, 8033860BIOAFT01SR, B-08033860038472
- EMDN Code
- A0102010102 Shearing biopsy guns
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000011601
Other devices from Biopsybell SRL
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (3)
- EUDAMED 1dc125a3-4e6a-4683-babb-f23c0ebb44e9
- EUDAMED 08033860038472|8033860BIOAFT01SR
- EUDAMED 08033860038472|B-08033860038472