Identity
- Trade Name
- Procedure Pack To Aid Infusion EUDAMED
- Device Name
- Procedure Pack To Aid Infusion EUDAMED
- Model / Reference
- 5907527942156 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907527942156 EUDAMED
- Basic UDI-DI
- 05907527942ProPackV8 EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- INTENDED USE The procedure pack should be used to support infusion or injection activities. It consists of: - 2x pre-injection cleaning swab, saturated with 70%v/V isopropyl alcohol, B.Braun REF 19579 – used to clean the skin before infusion or injection. - 2x sterile gauze swab, Paso-Trading, REF CH-001485, CE 2274 – used as a physical barrier to absorb small amounts of blood, wound exudate and to protect the wound from infection. - 2x sterile adhesive surgical dressing, Paso-Trading, REF CH-001476, CE 2274 – used for direct protection of the skin or fixing sterile gauze swab after infusion/injection procedure. The sterile gauze swab and sterile adhesive surgical dressing are suitable for the skin contact no longer than 24 hours. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Procedure Pack To Aid Infusion by Steripack Medical Poland Sp. Z O.o. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 05907527942ProPackV8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SteriPack Medical Poland Sp. z o.o.
- EUDAMED SRN
- PL-PR-000010981
Sources (1)
- EUDAMED d47ec4b0-7789-4862-a22e-711a937625be 61 fields · synced Oct 6, 2026