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Mini Prime tubing Set - Adult
EUDAMEDClass IIa (EU MDR)
Ref CME36002Model Bypass Tubing Pack including Oxygenator
Identity
- Trade Name
- Mini Prime tubing Set - Adult EUDAMED
- Model / Reference
- Bypass Tubing Pack including Oxygenator EUDAMEDCME36002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912587780 EUDAMED
- Basic UDI-DI
- 50564696TPackoxRJ EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Mini Prime tubing Set - Adult 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 | 50564696TPackoxRJ | 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 8094a4ad-bfc4-4c3b-93bf-77dd32d008f7 61 fields · synced Jul 9, 2026