Weldable Devices
Ref 234IR4A3.05Model BWB RING, BWB EXTENSION, BWB FEMALE JOINT, BWB MALE JOINT, WINGS ABUTMENT, WINGS EXTENSION, PROSTHETIC KIT BWB
Active
CE MDR
Valid until
20 Dec 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number007-00-06-MDR | Date27 Apr 2026 | StatusActive |
Certificates
- 007-00-06-MDR Active
Quality management system EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 27 Apr 2026
- Expires
- 20 Dec 2027
- Reason
- Add device or group
- 008-00-04-MDR Active
Technical documentation EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 5 Mar 2026
- Expires
- 20 Dec 2027
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Weldable Devices
- Model / Reference
- BWB RING, BWB EXTENSION, BWB FEMALE JOINT, BWB MALE JOINT, WINGS ABUTMENT, WINGS EXTENSION, PROSTHETIC KIT BWB, 234IR4A3.05
- Primary DI / UDI-DI
- +D748234IR4A3050K
- Basic UDI-DI
- ++D748WELDDEVICE58
- EMDN Code
- Q010299 Prosthetic dentistry devices - other
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026774
Other devices from Biotec S.R.L.
Properties
Other properties (13)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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