Introduttore
Ref TR1115OB
Introduttore (TR1115OB) is a Class IIa device made by Biopsybell SRL, registered in EUDAMED on 20 Jan 2026 (Basic UDI-DI 8033860BIOEFT01U5) with CE/MDR certificate IT349638 valid until 9 Feb 2030, withdrawn as of 24 Oct 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIT349638 | Date10 Feb 2026 | StatusWithdrawn |
| European Union | CE/MDD | Number8033860BIOEFT01U5 08033860002596 | Date20 Jan 2026 | StatusActive |
Official records
- EUDAMED public site 8033860BIOEFT01U5
Certificates
- IT349638 Withdrawn
Quality assurance EU MDR
- Certifier
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 10 Feb 2026
- Expires
- 9 Feb 2030
- Reason
- Other
Timeline
- Registered EUDAMED 8033860BIOEFT01U5
- Certificate issued EUDAMED IT349638
- Certificate expires EUDAMED IT349638
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device name
- Needles for Biopsy or Explant
- Model / reference
- TR1115OB
- Primary DI / UDI-DI
- 08033860002596
- Basic UDI-DI
- 8033860BIOEFT01U5, B-08033860002596
- EMDN code
- A01020102 Aspiration fine needles and kits
- Device class
- Class IIa
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000011601
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