Identity
- Device Name
- Sterile Customized ProcedurePak EUDAMED
- Model / Reference
- 97150547-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07313662440934 EUDAMED
- Basic UDI-DI
- 733243000000000116JU EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Sterile Customized ProcedurePak by Mölnlycke Health Care AB — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 733243000000000116JU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
- EUDAMED SRN
- SE-PR-000016902
Sources (2)
- EUDAMED e1893b17-e955-4343-ab5d-83afa6c82b03 61 fields · synced Oct 8, 2026
- EUDAMED 21ff6869-0e55-452d-a179-6d4c88d94444 61 fields · synced Oct 8, 2026