Identity
- Trade Name
- SpO2 sensor EUDAMEDNA FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- 01.57.471746 EUDAMEDSpO Sensor（Single-patient use）- adult FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413805477 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138SSG8 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
SpO2 sensor by Edan Instruments, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444138SSG8 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b8ff105f-8dbb-460a-9d5f-9c0b5917da1a 61 fields · synced Jun 8, 2026
- FDA UDI ef395f7f-cad1-41a5-9229-9066f5c5db25 32 fields · synced May 30, 2026