← Back to catalogue
0.3 Haemoconcentrator Set
EUDAMEDClass IIa (EU MDR)
Ref CME90047Model Bypass Tubing Pack including HaemoconcentratorRef CME90019Model Haemoconcentrator Set
Identity
- Trade Name
- 0.3 Haemoconcentrator Set EUDAMED0.3 Haemoconcentrator Tubing Pack EUDAMED
- Model / Reference
- Bypass Tubing Pack including Haemoconcentrator EUDAMEDCME90047 EUDAMEDHaemoconcentrator Set EUDAMEDCME90019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912588640 EUDAMED05060491611517 EUDAMED
- Basic UDI-DI
- 50564696TPackHaemo52 EUDAMEDB-05060491611517 EUDAMED
- EMDN Code
- F0301 HAEMOFILTRATION-HAEMODIAFILTRATION KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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
0.3 Haemoconcentrator Set by Chalice Medical Ltd — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 50564696TPackHaemo52 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 50564696TPackHaemo52 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- Chalice Medical Europe GmbH DE-AR-000007891
Sources (2)
- EUDAMED 35d582e2-ab51-4808-ba03-1d74752739e0 61 fields · synced Aug 1, 2026
- EUDAMED 9192ae72-e68e-4e0f-a50b-833b89be8f50 61 fields · synced May 18, 2026