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SPO2 SPU Infant Wrap Sensor M1132A
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803205841
Identity
- Trade Name
- SPO2 SPU Infant Wrap Sensor M1132A EUDAMEDSpO2 Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- SPO2 Sensors EUDAMEDM1132A Infant Disposable SpO2 Sensor FDA UDI
- Model / Reference
- 989803205841 EUDAMEDSPO2 SPU Infant Wrap Sensor M1132A FDA UDI
- Description
- M1132A Infant Disposable SpO2 Sensor FDA UDI
Identifiers
- Catalog Number
- 989803205841 FDA UDI
- Primary DI / UDI-DI
- 20884838102662 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838102662 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
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
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
MR Unsafe FDA UDI
SPO2 SPU Infant Wrap Sensor M1132A by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-20884838102662 | 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 6c59f4c7-1486-4aa2-8a0d-e3ee901ad68d 61 fields · synced Oct 7, 2026
- FDA UDI 10198313-14b1-4afd-80be-645dbdabe38a 36 fields · synced May 30, 2026