Identity
- Trade Name
- ETCO2 sensor EUDAMED
- Device Name
- ETCO2 sensor EUDAMED
- Model / Reference
- CTM-ZL01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970706360699 EUDAMED
- Basic UDI-DI
- B-06970706360699 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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ETCO2 sensor by Orantech Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171828 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970706360699 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- FDA Applicant
- Orantech, Inc.
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED c7fb2610-79fc-42dd-8f86-05c8f01ac5cc 85 fields · synced Jun 18, 2026
- FDA 510(k) K171828 1 fields · synced May 18, 2026