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Xssential Rapid Delivery Procedure Pack
EUDAMEDClass IIa (EU MDR)
Ref SYNRIFS40Model ANG 02Ref SYNPC0840NLModel INV 02Ref SYN2023
Identity
- Trade Name
- Xssential Rapid Delivery Procedure Pack EUDAMED
- Device Name
- Angiography Pack-02 EUDAMEDINV (Interventional Radiology) EUDAMED
- Model / Reference
- ANG 02 EUDAMEDSYNRIFS40 EUDAMEDINV 02 EUDAMEDSYNPC0840NL EUDAMEDSYN2023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834367 EUDAMED05065024079079 EUDAMED05065024079185 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP009ZH EUDAMED5065021834SYNPP011Z4 EUDAMED
- EMDN Code
- C0104010199 CARDIAC ANGIOGRAPHY DIAGNOSTIC DEVICES - OTHER EUDAMEDZ11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Facilitates vascular imaging and interventions with sterile instruments for angiographic procedures. EUDAMEDProvides sterile instruments for minimally invasive surgeries using imaging guidance. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
The Xssential Rapid Delivery Procedure Pack (XRDP) is a sterile, angiography-compatible procedure pack designed for sterile instrument administration during vascular imaging and interventions. This innovative device facilitates safe and efficient procedures by utilizing sterile instruments for angiographic procedures.
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 | 5065021834SYNPP009ZH | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (3)
- EUDAMED 86822012-c068-4558-a070-6944cfd823ee 61 fields · synced Aug 1, 2026
- EUDAMED 4110e28c-157b-496b-ba7e-5ef7c41178c5 61 fields · synced May 18, 2026
- EUDAMED fbd18474-e669-4a0f-9522-493c2c7a7532 61 fields · synced May 18, 2026