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Xssential Rapid Delivery Procedure Pack
EUDAMEDClass IIa (EU MDR)
Ref SYN2035Model ANG 02
Identity
- Trade Name
- Xssential Rapid Delivery Procedure Pack EUDAMED
- Device Name
- Angiography Pack-02 EUDAMED
- Model / Reference
- ANG 02 EUDAMEDSYN2035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065024079123 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP009ZH EUDAMED
- EMDN Code
- C0104010199 CARDIAC ANGIOGRAPHY DIAGNOSTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Facilitates vascular imaging and interventions with sterile instruments for angiographic procedures. 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 | 5065021834SYNPP009ZH | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED c4271540-5ca8-4a8e-91cb-d897f6e89308 61 fields · synced Jun 18, 2026