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Haemoperfusion Tubing Pack
EUDAMEDClass IIa (EU MDR)
Ref CME72001Model Ancillary ComponentsRef CME72001/CH
Identity
- Trade Name
- Haemoperfusion Tubing Pack EUDAMED
- Model / Reference
- Ancillary Components EUDAMEDCME72001 EUDAMEDCME72001/CH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912585441 EUDAMED05060912587261 EUDAMED
- Basic UDI-DI
- 50564696TPackacNW EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) 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
Haemoperfusion Tubing Pack 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 | 50564696TPackacNW | 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 4f10fc12-c98d-4323-b88b-77751a2765b2 61 fields · synced Jul 18, 2026
- EUDAMED 8c6ca7fb-a3e0-4f32-9aed-17878b5da2bc 61 fields · synced May 18, 2026