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TruePhysio® Rapid Exchange Pressure Microcatheter
EUDAMEDClass III (EU MDR)
Ref 1-14-1
Identity
- Trade Name
- TruePhysio® Rapid Exchange Pressure Microcatheter EUDAMED
- Device Name
- TruePhysio® Rapid Exchange Pressure Microcatheter EUDAMED
- Model / Reference
- 1-14-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971318440014 EUDAMED
- Basic UDI-DI
- B-06971318440014 EUDAMED
- EMDN Code
- C0104010101 CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Angiographic catheter, single-use
TruePhysio® Rapid Exchange Pressure Microcatheter by Insight Lifetech Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06971318440014 | Class III | Active |
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Manufacturer
- Manufacturer
- Insight Lifetech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011205
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (1)
- EUDAMED bad6c79b-d91e-4c49-b55d-bece02875108 61 fields · synced Jun 19, 2026