Drop Control Device
by Gem SRL Italy EUDAMED
Ref G2 DCD-210-8TModel G2 DCD-210-8T
EMDN C900180
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number80319028AD | Date5 Nov 2024 | StatusActive |
| European Union | CE/MDR | Number80319028AD | Date5 Nov 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- 0425-MDR-030094-00 Issued
Quality assurance EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 12 Sep 2024
- Expires
- 11 Sep 2029
Specification
- Model / Reference
- G2 DCD-210-8T, G2 DCD-210-8T
- Primary DI / UDI-DI
- 08031902000104, D-G2DCD-210-8TRA
- Basic UDI-DI
- 80319028AD, B-G2DCD-210-8TRA
- EMDN Code
- C900180 Haemostasis systems - accessories
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000012892
Other devices from Gem 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 b7928ced-1fee-49f6-ba23-d5d29e1b8f74
- EUDAMED D-G2DCD-210-8TRA|B-G2DCD-210-8TRA