Identity
- Trade Name
- Capnograph EUDAMED
- Device Name
- Capnograph EUDAMED
- Model / Reference
- CA10M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040104681 EUDAMED
- Basic UDI-DI
- 69450401CA10MBY EUDAMED
- Direct Marketing DI
- 06945040104681 EUDAMED
- EMDN Code
- Z1203020401 CARBON DIOXIDE ANALYSERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Capnograph by Contec Medical Systems Co., Ltd. — Class IIa — 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 | 69450401CA10MBY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 03586422-cd4f-4731-8e82-29fc89021c2c 61 fields · synced Jun 19, 2026