Sterile Customized ProcedurePak
by Mölnlycke Health Care AB 752 variants
Ref 97000524-17
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 | Number733243000000000138K6 07313662567358 | Date3 Jun 2026 | 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- Withdrawn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
- Sterile Customized ProcedurePak
- Model / Reference
- 97000524-17
- Primary DI / UDI-DI
- 07313662567358
- Basic UDI-DI
- 733243000000000138K6
- EMDN Code
- V0599 Clinical procedures kits not included in other classes - other
- Device Class
- Class IIb
- Medical Purpose
- The intention of co-packing components into trays is to replace a large number of individually packaged items and generate savings in time for surgery procedures.
Manufacturer details
- EUDAMED SRN
- SE-PR-000016902