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omegapack Zestaw do operacji kardiochirurgicznych 79 - STYMULATORY SERCA
EUDAMEDClass IIa (EU MDR)
Ref OP-KAR-01579
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- omegapack Zestaw do operacji kardiochirurgicznych 79 - STYMULATORY SERCA EUDAMED
- Device Name
- omegapack Zestaw do operacji kardiochirurgicznych 79 - STYMULATORY SERCA EUDAMED
- Model / Reference
- OP-KAR-01579 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904109616009 EUDAMED
- Basic UDI-DI
- B-05904109616009 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
omegapack Zestaw do operacji kardiochirurgicznych 79 - STYMULATORY SERCA by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class IIa — MDD…
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-05904109616009 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED 4d090b36-f6ca-4242-bc54-99ea0409e2b1 61 fields · synced Oct 8, 2026