SPO2 SPU Neo-Inf-Adlt Wrap Sensor M1133A
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- SPO2 SPU Neo-Inf-Adlt Wrap Sensor M1133A EUDAMEDSpO2 Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- SPO2 Sensors EUDAMEDM1133A Neonatal / Infant / Adult Disposable SpO2 Sensor FDA UDI
- Model / Reference
- 989803205851 EUDAMEDSPO2 SPU Neo-Inf-Adlt Wrap Sensor M1133A FDA UDI
- Description
- M1133A Neonatal / Infant / Adult Disposable SpO2 Sensor FDA UDI
Identifiers
- Catalog Number
- 989803205851 FDA UDI
- Primary DI / UDI-DI
- 20884838102679 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838102679 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
Single Use
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
SPO2 SPU Neo-Inf-Adlt Wrap Sensor M1133A by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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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-20884838102679 | 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 201e186a-ad51-4dd6-a25c-12ef2984076c 61 fields · synced Oct 6, 2026
- FDA UDI d1c11913-7ca1-4252-9271-c14d32516521 36 fields · synced May 30, 2026