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Chartis Pulmonary Assessment System Catheter
EUDAMEDClass IIa (EU MDR)
Ref CHR-CA-12.0
Identity
- Trade Name
- Chartis Pulmonary Assessment System Catheter EUDAMED
- Device Name
- Chartis Catheter EUDAMED
- Model / Reference
- CHR-CA-12.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811907030911 EUDAMED
- Basic UDI-DI
- 0081190703CHRCALQ EUDAMED
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Chartis Pulmonary Assessment System Catheter by Pulmonx Corporation — 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 | 0081190703CHRCALQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pulmonx Corporation
- EUDAMED SRN
- US-MF-000038432
- Authorised Representative
- Pulmonx GmbH DE-AR-000035276
Sources (1)
- EUDAMED e4796c04-3e4e-4e60-b254-7fe85490b16c 61 fields · synced Jun 19, 2026