Identity
- Trade Name
- ETCO2 sensor EUDAMED
- Device Name
- ETCO2 sensor EUDAMED
- Model / Reference
- CTS-HT01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691962618 EUDAMED
- Basic UDI-DI
- B-06941691962618 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
Yes
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
No
EUDAMED
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-06941691962618 | 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 (1)
- EUDAMED 133de0c5-7d90-47c0-b893-dc1f816c0eff 61 fields · synced Jun 18, 2026