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1.2 Haemoconcentrator Set
EUDAMEDClass IIa (EU MDR)
Ref CME90046Model Bypass Tubing Pack including Haemoconcentrator
Identity
- Trade Name
- 1.2 Haemoconcentrator Set EUDAMED
- Model / Reference
- Bypass Tubing Pack including Haemoconcentrator EUDAMEDCME90046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912588633 EUDAMED
- Basic UDI-DI
- 50564696TPackHaemo52 EUDAMED
- EMDN Code
- F0301 HAEMOFILTRATION-HAEMODIAFILTRATION KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
1.2 Haemoconcentrator Set by Chalice Medical Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (1)
- EUDAMED 99c480f7-670f-4c88-a97c-4f2b873f1837 61 fields · synced Jun 19, 2026