Identity
- Trade Name
- ETCO2 sensor EUDAMEDFDA UDI
- Generic Name
- Carbon dioxide monitor FDA UDI
- Device Name
- ETCO2 sensor EUDAMEDETCO2 Sensor Respironics Compatible, Mainstream, 3.0M FDA UDI
- Model / Reference
- CTM-RP01 EUDAMEDFDA UDI
- Description
- ETCO2 Sensor Respironics Compatible, Mainstream, 3.0M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970706360668 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970706360668 EUDAMED
- 510(k) Number
- K171828 FDA UDI
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- R020108 RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS EUDAMED
- GMDN Term
- Carbon dioxide monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ETCO2 sensor by Orantech Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970706360668 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED 2d0efd61-b612-439d-a3ef-a86adc20c5cb 61 fields · synced Jun 18, 2026
- FDA UDI c92509fb-7530-4c0a-b905-478246a1606b 34 fields · synced May 29, 2026