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Haemoperfusion Tubing Pack with Neonatal PMP Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref CME72003Model ECMO Tubing Pack including Oxygenator
Identity
- Trade Name
- Haemoperfusion Tubing Pack with Neonatal PMP Oxygenator EUDAMED
- Model / Reference
- ECMO Tubing Pack including Oxygenator EUDAMEDCME72003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912588527 EUDAMED
- Basic UDI-DI
- 50564696TpackECoxG9 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS 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 with Neonatal PMP Oxygenator 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 | 50564696TpackECoxG9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED ab274c8c-35ab-47d1-92ea-2204e48c557a 61 fields · synced Jul 9, 2026