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StoreProtect®
EUDAMEDClass III (EU MDR)
Ref SPRT2000Model StoreProtect® capacity 2000 mL
Identity
- Trade Name
- StoreProtect® EUDAMED
- Device Name
- StoreProtect® - Container filled with solution for perfusion or preservation of organs intended for transplantation EUDAMED
- Model / Reference
- StoreProtect® capacity 2000 mL EUDAMEDSPRT2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906874879016 EUDAMED
- Basic UDI-DI
- B-05906874879016 EUDAMED
- EMDN Code
- C0399 CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
StoreProtect® by Carnamedica Sp Z O O — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05906874879016 | Class III | Active |
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Manufacturer
- Manufacturer
- Carnamedica Sp. z o.o.
- EUDAMED SRN
- PL-MF-000017531
Sources (1)
- EUDAMED bfb8ebfb-6311-4c49-a6ac-39f8848529ee 61 fields · synced Jul 28, 2026