Identity
- Trade Name
- EXTesia EUDAMED
- Device Name
- EXTesia Introducer Sheath Set EUDAMED
- Model / Reference
- 2IS050738SSI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941358012472 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
Category: Interventional radiology percutaneous-access kit, single-use
EXTesia by Curatia Medical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
- Access Needle — Mermaid Medical A/S · Class I
- SWL-Pathfinder — SWL Medizin GmbH · Class III
- Mini Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Introducer Set — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
- Arterial Catheter Kit — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
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 a7f48c2d-539f-4831-98dc-f685055a7d7a 61 fields · synced Jun 18, 2026