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Standard Adult ECC Tubing Pack

EUDAMED

Class IIa (EU MDR)

Ref CME21003Model Ancillary Components

by Chalice Medical Ltd

Identity

Trade Name
Standard Adult ECC Tubing Pack EUDAMED
Model / Reference
Ancillary Components EUDAMED
CME21003 EUDAMED

Identifiers

Primary DI / UDI-DI
05060912586295 EUDAMED
Basic UDI-DI
50564696TPackacNW EUDAMED
EMDN Code
C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED

Classification

Device Class
Class IIa 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

Standard Adult ECC 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

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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 714cb694-a17b-41ac-a2c9-e85fa3b85e20 61 fields · synced Jun 18, 2026