Carilex
by Carilex Medical, Inc 6 variants
Ref S1002-3052
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471987369S1XXXRV 04719873696734 | Date6 Feb 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Negative Pressure Wound Therapy System
- Model / Reference
- S1002-3052
- Primary DI / UDI-DI
- 04719873696734
- Basic UDI-DI
- 471987369S1XXXRV
- Direct Marketing DI
- 04719873696734
- EMDN Code
- Z12019003 Wound treatment equipment
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000002145
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Carilex Medical, Inc.
Properties
Other properties (13)
- Sterile: No
- 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