PTS Personalized Tourniquet System for Blood Flow Restriction
by Delfi Medical Innovations Inc. 4 variants
Ref 9-2500-002BFR_M
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++M9959IBFRREUD7 +M99592500002BFRM1 | Date2 Feb 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- PTS Personalized Tourniquet System for Blood Flow Restriction
- Model / Reference
- 9-2500-002BFR_M
- Primary DI / UDI-DI
- +M99592500002BFRM1
- Basic UDI-DI
- ++M9959IBFRREUD7
- EMDN Code
- V9003 Tourniquets
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CA-MF-000004434
- Authorised representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Other devices from Delfi Medical Innovations 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