Identity
- Trade Name
- Sidestream CO2 Sensor EUDAMEDSidestream CO2 Module FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Device Name
- CO2 Sensors EUDAMEDSidestream CO2 Sensor FDA UDI
- Model / Reference
- 989803144591 EUDAMEDSidestream CO2 Sensor FDA UDI
- Description
- Sidestream CO2 Sensor FDA UDI
Identifiers
- Catalog Number
- 989803144591 FDA UDI
- Primary DI / UDI-DI
- 00884838072190 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838072190 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, carbon dioxide FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Sidestream CO2 Sensor by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838072190 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 7ea6c049-fb02-4f42-8d3c-38efbf9e4048 61 fields · synced Jun 20, 2026
- FDA UDI db2bb1fb-71d1-4e03-a1ed-4525c5cac347 36 fields · synced May 29, 2026