Reusable Adult SpO2 Sensor
by Philips Medizin Systeme Böblingen GmbH 2 variants
Ref 989803144371
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-00884838010215 00884838010215 | Date14 May 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00884838010215 | Date11 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- Withdrawn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 Adult SpO2 Sensor EUDAMEDSpO2 Sensor GUDID
- Generic Name
- Pulse oximeter probe, reusable
- Device Name
- SPO2 Sensors
- Model / Ref / Catalog
- 989803144371, Reusable Adult SpO2 Sensor
- Primary DI / UDI-DI
- 00884838010215
- Basic UDI-DI
- B-00884838010215
- 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 | 989803144371 | Reusable Adult SpO2 Sensor |
| 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