Identity
- Trade Name
- EXTesia EUDAMED
- Device Name
- EXTesia Introducer Sheath Set EUDAMED
- Model / Reference
- 2IS042521SSI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941358012267 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 Introducer Sheath Set is a reliable medical device designed for introducing instruments into anatomical structures, offering improved safety and efficacy. This Class IIa medical device is equipped with advanced features such as self-testing capabilities, allowing for real-time monitoring of the introduction process. The EXTesia set also has a sterile design, making it ideal for use in clinical settings where sterility is paramount.
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 9e4615cb-952c-4b8a-b9da-f755de93ed76 61 fields · synced Oct 6, 2026