Reusable SpO2 Sensor Adult
by Philips Medizin Systeme Böblingen GmbH
Ref 989803128591
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00884838010239 00884838010239 | Date14 May 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00884838010239 | Date21 Nov 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Reusable SpO2 Sensor Adult EUDAMEDSpO2 Sensor GUDID
- Generic Name
- Pulse oximeter probe, reusable
- Device Name
- SPO2 Sensors
- Model / Ref / Catalog
- 989803128591, Reusable SpO2 Sensor Adult
- Primary DI / UDI-DI
- 00884838010239
- Basic UDI-DI
- B-00884838010239
- FDA Product Code
- DQA
- EMDN Code
- Z12030280 Vital signs monitoring instruments - hardware accessories
- GMDN Term
- Pulse oximeter probe, reusable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 870.2700
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 989803128591 | Reusable SpO2 Sensor Adult |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000006026
Other devices from Philips Medizin Systeme Böblingen GmbH
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Properties
Other properties (22)
- 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: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No