Praxiject SF
by MedXL Inc
Ref 3705-4Model 3704
Active
CE MDR
Valid until
3 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0682686NS001UK 10682686005271 | Date16 Jun 2026 | StatusActive |
Certificates
- 28620153629 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 24 Jul 2023
- Expires
- 3 Jan 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Praxiject
- Model / Reference
- 3704, 3705-4
- Primary DI / UDI-DI
- 10682686005271
- Basic UDI-DI
- 0682686NS001UK
- Direct Marketing DI
- 10682686005271
- EMDN Code
- A02010701 Prefilled syringes with sterile physiological solution
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CA-MF-000011111
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from MedXL Inc
Properties
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