Identity
- Device Name
- REBOA™ Catheter Convenience Kit (EU) EUDAMEDREBOA Catheter Convenience Kit (EU) EUDAMED
- Model / Reference
- KT1835E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00863092000132 EUDAMED
- Basic UDI-DI
- B-00863092000132 EUDAMED08630920001KT1835ES6 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
REBOA™ Catheter Convenience Kit (EU) by Prytime Medical Devices Inc. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00863092000132 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00863092000132 | Class I | Active |
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Manufacturer
- Manufacturer
- Prytime Medical Devices Inc.
- EUDAMED SRN
- US-MF-000008225
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED ba0a4dbf-ee3f-4f67-8644-7d2745650ce3 61 fields · synced Jul 8, 2026
- EUDAMED 288a0525-60a2-4aa1-b665-b625146f5d5a 61 fields · synced May 18, 2026