Identity
- Trade Name
- EXTesia EUDAMED
- Device Name
- EXTesia Introducer Sheath Set EUDAMED
- Model / Reference
- 2IS050521SSN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941358009311 EUDAMED
- Basic UDI-DI
- 697022652107FS EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia EUDAMED
Clinical & Handling
Sterile
Yes
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
EXTesia by Curatia Medical Limited — 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 | 697022652107FS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Curatia Medical Limited
- EUDAMED SRN
- CN-MF-000015976
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED 79afe85c-ed3c-4b13-bf97-0ac6a5cdd1ee 61 fields · synced Jun 19, 2026