Surgical glue Glubran 2 - Phlebology
by Gem SRL EUDAMED
Active
Ref G-NB2-PHLEModel G-NB-2;G-NB2-75;G-NB2-60; G-NB2-50; G-NB2-35 ;G-NB2S-25
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0019240225 | Date12 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ0019240225 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 12 Mar 2025
- Expires
- 15 May 2029
- Reason
- Add device or group
- CVD0027240225 Supplemented
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 12 Mar 2025
- Expires
- 15 May 2029
- Reason
- Add device or group
Specification
- Device Name
- Surgical Glue Glubran 2
- Model / Reference
- G-NB-2, G-NB2-75, G-NB2-60, G-NB2-50, G-NB2-35, G-NB2S-25, G-NB2-PHLE
- Primary DI / UDI-DI
- 08031902000845
- Basic UDI-DI
- 803190219X
- EMDN Code
- H90010102 Synthetic glues
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000012892
Other devices from Gem SRL
Properties
Show properties
Other properties (11)
- 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