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Xssential Rapid Delivery Procedure Pack
EUDAMEDClass IIa (EU MDR)
Ref SYNCB18100Model INV 02
Identity
- Trade Name
- Xssential Rapid Delivery Procedure Pack EUDAMED
- Device Name
- INV (Interventional Radiology) EUDAMED
- Model / Reference
- INV 02 EUDAMEDSYNCB18100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065024079147 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP011Z4 EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Provides sterile instruments for minimally invasive surgeries using imaging guidance. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Xssential Rapid Delivery Procedure Pack by SYNDEO Medical — 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 | 5065021834SYNPP011Z4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED 2111cb93-1272-433e-92e5-6a4bd542d5fa 61 fields · synced Jun 20, 2026