Identity
- Device Name
- Sterile Customized ProcedurePak EUDAMED
- Model / Reference
- 97152779-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07313662440835 EUDAMED
- Basic UDI-DI
- 733243000000000109JX EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- 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. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
The Sterile Customized ProcedurePak is a cutting-edge medical device designed for co-packing components into trays, offering significant time savings and resource efficiency. This device has undergone comprehensive testing to ensure its sterility and safety for surgical procedures. By utilizing our proprietary technology, you can streamline your workflow and improve patient outcomes.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 733243000000000109JX | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
- EUDAMED SRN
- SE-PR-000016902
Sources (1)
- EUDAMED f50ab942-b687-426b-ab71-54d47796c437 61 fields · synced Oct 6, 2026