Identity
- Trade Name
- Soldier EUDAMED
- Device Name
- Soldier High Flow Microcatheter EUDAMED
- Model / Reference
- S27-SP-130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853359008186 EUDAMED
- Basic UDI-DI
- B-00853359008186 EUDAMED
- EMDN Code
- C01050202 PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Soldier by Embolx, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00853359008186 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Embolx, Inc.
- EUDAMED SRN
- US-MF-000025650
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 8ce23fba-9745-4234-bafe-bb52c6afd188 61 fields · synced May 23, 2026