Moon
by Biopsybell SRL Italy EUDAMED
Ref MN2111LEC
EMDN A019012
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
- Expiring (legacy directive)
- Not covered
European Union — CE/MDR, CE/MDD Expiring (legacy directive)
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- IT349638 Withdrawn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 Explant
- Model / Reference
- MN2111LEC
- Primary DI / UDI-DI
- 08033860045036
- Basic UDI-DI
- 8033860BIOEFT01U5, B-08033860045036
- EMDN Code
- A019012 Breast nodules and other structures localisation needles and systems
- 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 (2)
- EUDAMED 0e7807e6-98b5-457f-a6b7-9f92b6bbfa17
- EUDAMED 08033860045036|B-08033860045036