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Haemofilter Tubing Pack
EUDAMEDClass IIa (EU MDR)
Ref CME72004Model Bypass Tubing Pack including Haemoconcentrator
Identity
- Trade Name
- Haemofilter Tubing Pack EUDAMED
- Model / Reference
- Bypass Tubing Pack including Haemoconcentrator EUDAMEDCME72004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912586462 EUDAMED
- Basic UDI-DI
- 50564696TPackHaemo52 EUDAMED
- EMDN Code
- F0301 HAEMOFILTRATION-HAEMODIAFILTRATION KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
For patients requiring hemofiltration therapy, the Haemofilter Tubing Pack is a versatile and reliable device designed for safe and effective application of this medical treatment. With its Class IIa regulatory classification, it meets strict standards for sterility, purity, and safety.
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 | 50564696TPackHaemo52 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- Chalice Medical Europe GmbH DE-AR-000007891
Sources (2)
- EUDAMED 0e430f15-b1fa-42d4-8c90-86b3d1926e18 61 fields · synced Sep 18, 2026
- EUDAMED 322b63fc-2a72-460f-be8f-830940dc0119 61 fields · synced Sep 18, 2026