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1.2 Haemoconcentrator Tubing Pack
EUDAMEDClass IIa (EU MDR)
Ref CME90021Model Haemoconcentrator Set
Identity
- Trade Name
- 1.2 Haemoconcentrator Tubing Pack EUDAMED
- Model / Reference
- Haemoconcentrator Set EUDAMEDCME90021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491611531 EUDAMED
- Basic UDI-DI
- B-05060491611531 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
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
1.2 Haemoconcentrator Tubing Pack by Chalice Medical Ltd — Class IIa — 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-05060491611531 | 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 dea1bc89-3e43-4235-afc9-ee8ad7dea450 61 fields · synced Jul 16, 2026