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Kaniula pozaustrojowej pompy wspomagania serca POLVAD–MEV
EUDAMEDClass III (EU MDR)
Ref 05903981371624Model Kaniula napływowa IC-N 90
by F.R.K. "INTRA-CORDIS" Spółka z ograniczoną odpowiedzialnością
Identity
- Device Name
- Kaniula pozaustrojowej pompy wspomagania serca POLVAD–MEV EUDAMED
- Model / Reference
- Kaniula napływowa IC-N 90 EUDAMED05903981371624 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903981371624 EUDAMED
- Basic UDI-DI
- B-05903981371624 EUDAMED
- EMDN Code
- C03010499 EXTRACORPOREAL CIRCULATION CANNULAS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: External ventricular circulatory assist system
Kaniula pozaustrojowej pompy wspomagania serca POLVAD–MEV by F.R.K. "INTRA-CORDIS" Spółka z ograniczoną odpowiedzialnością — Class III — MDD — listed in EUDAMED
Similar devices
Also classified as External ventricular circulatory assist system.
- Art. HLS cannula OD = 17 Fr (5.7 mm) 3/8" connector with LL, insertion length 23 cm — Maquet Cardiopulmonary GmbH · Class III
- EXCOR® — Berlin Heart, Inc. · Class III
- Art. HLS cannula OD = 15 Fr (5.0 mm) 3/8" connector with LL, insertion length 15 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Driving tube — Berlin Heart GmbH · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Venous HLS Cannula OD= 25Fr (8.3 mm) 3/8" connector without LL, insertion length 55 cm — Maquet Cardiopulmonary GmbH · Class IIa
- EXCOR® — Berlin Heart, Inc. · Class III
- Art. HLS cannula OD = 23 Fr (7.7 mm) 3/8" connector with LL, insertion length 23 cm — Maquet Cardiopulmonary GmbH · Class IIa
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-05903981371624 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000019081
Sources (1)
- EUDAMED a0ebad41-e451-43f9-9cd4-b5d421fd257d 61 fields · synced Oct 7, 2026