Paradigm Revolution
by Conmed Corporation 12 variants
Ref PRPC
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084585408502CZ 20845854082925 | Date7 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number20845854082925 | Date13 Jun 2023 | StatusListed |
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- Withdrawn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
- United States
Specification
- Generic Name
- Leg/knee cushion
- Device Name
- Orthopedic, Non-active, Stabilization, Hand, Sterile
- Model / Ref / Catalog
- PRPC
- Primary DI / UDI-DI
- 20845854082925
- Basic UDI-DI
- 084585408502CZ
- FDA Product Code
- KQZ
- EMDN Code
- V080302 Patient positioning medical cushions
- GMDN Term
- Leg/knee cushion
- Device Class
- Class I
- Regulation Number
- 888.5890
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties
Other properties (18)
- 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No