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Flow Sensor Adult / Pediatric
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803144661Model Flow Sensors
Identity
- Trade Name
- Flow Sensor Adult / Pediatric EUDAMEDSpirometry Sensor FDA UDI
- Generic Name
- Monitoring spirometer, electrical FDA UDI
- Device Name
- Flow Sensors EUDAMEDFlow Sensor Adult / Pediatric FDA UDI
- Model / Reference
- Flow Sensors EUDAMED989803144661 EUDAMEDFlow Sensor Adult / Pediatric FDA UDI
- Description
- Flow Sensor Adult / Pediatric FDA UDI
Identifiers
- Catalog Number
- 989803144661 FDA UDI
- Primary DI / UDI-DI
- 20884838072231 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838072231 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Monitoring spirometer, electrical FDA UDI
Classification
- Device Class
- Class IIa 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Flow Sensor Adult / Pediatric by Philips Medizin Systeme Böblingen GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20884838072231 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED b75814e6-cec3-4a8e-8eeb-78f8c0210874 61 fields · synced Oct 6, 2026
- FDA UDI b1b20510-dc22-4195-9b4a-2905dc827940 36 fields · synced May 30, 2026