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Cardiac output cables
EUDAMEDClass I (EU MDR)
Ref COCA-MR01-01Ref COCA-MR03-01Ref COCA-MR02-01Ref COCA-PH01-01Ref COCA-SL01-01Ref COCA-EW03-01Ref COCA-MQ-36
Identity
- Trade Name
- Cardiac output cables EUDAMED
- Device Name
- Cardiac output cables EUDAMED
- Model / Reference
- COCA-MR01-01 EUDAMEDCOCA-MR03-01 EUDAMEDCOCA-MR02-01 EUDAMEDCOCA-PH01-01 EUDAMEDCOCA-SL01-01 EUDAMEDCOCA-EW03-01 EUDAMEDCOCA-MQ-36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691982821 EUDAMED06941691982845 EUDAMED06941691982838 EUDAMED06941691982869 EUDAMED06941691982876 EUDAMED06941691986003 EUDAMED06941691973683 EUDAMED
- Basic UDI-DI
- 69416919ORANTECH19RA EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Cardiac output cables by Orantech Inc. — Class I — 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 | 69416919ORANTECH19RA | Class I | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (7)
- EUDAMED 78409871-52fc-4f0d-90e1-b6623d888856 61 fields · synced Aug 4, 2026
- EUDAMED 4a30f9ad-8427-4177-a584-bfb60b4fc240 61 fields · synced May 17, 2026
- EUDAMED b15888e2-6748-44df-b765-cca22326fdc7 61 fields · synced May 18, 2026
- EUDAMED 6f876eea-bcce-4614-a9b2-7841fab57e64 61 fields · synced May 18, 2026
- EUDAMED f5410c99-781b-4280-b6f4-ce163cafc0af 61 fields · synced May 18, 2026
- EUDAMED 0a8d2533-79af-4531-a914-5f5fcf305084 61 fields · synced May 18, 2026
- EUDAMED 87625795-6662-43fe-9ae6-d0faf13e7c84 61 fields · synced May 18, 2026