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High Flow Pigtail
EUDAMEDClass IIa (EU MDR)
Ref CME90062Model Ancillary ComponentsRef CM5731
Identity
- Trade Name
- High Flow Pigtail EUDAMED
- Model / Reference
- Ancillary Components EUDAMEDCME90062 EUDAMEDCM5731 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912581337 EUDAMED05060491616987 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
- Ireland 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
High Flow Pigtail 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 02485199-f777-4a72-b4d5-ad6bcf1b0a86 61 fields · synced Jul 11, 2026
- EUDAMED 5b148bc0-ba2b-4285-97b7-563288777039 61 fields · synced May 17, 2026