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ETCO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref CTS-MR01Ref CTM-UC01Ref CTM-CN01Ref CTM-ED01Ref CTM-BN01Ref CTS-PH01Ref CTS-PS01Ref CTM-HWT01Ref CTM-MR01Ref CTM-NK01Ref CTM-MD01Ref CTM-PH01Ref CTS-RP01
Identity
- Trade Name
- ETCO2 sensor EUDAMED
- Device Name
- ETCO2 sensor EUDAMED
- Model / Reference
- CTS-MR01 EUDAMEDCTM-UC01 EUDAMEDCTM-CN01 EUDAMEDCTM-ED01 EUDAMEDCTM-BN01 EUDAMEDCTS-PH01 EUDAMEDCTS-PS01 EUDAMEDCTM-HWT01 EUDAMEDCTM-MR01 EUDAMEDCTM-NK01 EUDAMEDCTM-MD01 EUDAMEDCTM-PH01 EUDAMEDCTS-RP01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970706360750 EUDAMED06941691985389 EUDAMED06941691985365 EUDAMED06941691985334 EUDAMED06941691985402 EUDAMED06970706360729 EUDAMED06970706360736 EUDAMED06941691985372 EUDAMED06970706360705 EUDAMED06941691962878 EUDAMED06941691985396 EUDAMED06970706360675 EUDAMED06970706360712 EUDAMED
- Basic UDI-DI
- B-06970706360750 EUDAMEDB-06941691985389 EUDAMEDB-06941691985365 EUDAMEDB-06941691985334 EUDAMEDB-06941691985402 EUDAMEDB-06970706360729 EUDAMEDB-06970706360736 EUDAMEDB-06941691985372 EUDAMEDB-06970706360705 EUDAMEDB-06941691962878 EUDAMEDB-06941691985396 EUDAMEDB-06970706360675 EUDAMEDB-06970706360712 EUDAMED
- EMDN Code
- R020108 RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
ETCO2 sensor by Orantech Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970706360750 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (13)
- EUDAMED 31b9b6ea-7842-48c8-a56a-52d2d362b8bc 61 fields · synced Aug 2, 2026
- EUDAMED eebbfc9d-8a1c-4826-a09d-9775b0d90132 61 fields · synced May 17, 2026
- EUDAMED 1ebdb4ef-2f4c-4819-b344-1a6c03972785 61 fields · synced May 17, 2026
- EUDAMED a66ce2f7-5470-48a5-ba3b-a139d8e34c50 61 fields · synced May 17, 2026
- EUDAMED 6a2e960b-4630-4c98-a51f-ee8cde251f17 61 fields · synced May 17, 2026
- EUDAMED 71520a1b-2e2b-4f63-8e7f-b7ff24cc5c22 61 fields · synced May 18, 2026
- EUDAMED 696c6657-3c55-4bca-825c-f7205aba0480 61 fields · synced May 18, 2026
- EUDAMED ee1008cf-2abb-4d38-a50f-deafb80d414f 61 fields · synced May 18, 2026
- EUDAMED ca18f6ae-35aa-4e57-8946-427e17564c1f 61 fields · synced May 18, 2026
- EUDAMED 4115b231-2433-4cda-b9f1-f3fa0b54bd38 61 fields · synced May 18, 2026
- EUDAMED 1f410173-4592-4c1f-9233-cac15c5da446 61 fields · synced May 18, 2026
- EUDAMED 0f9b791d-78dc-4bde-9283-4396968c5266 61 fields · synced May 18, 2026
- EUDAMED 9019e9ac-ed24-457f-a476-2fe98fe71eec 61 fields · synced May 19, 2026