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pulse oximeter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CMS50DLModel CMS50DL, CMS50D
Identity
- Trade Name
- pulse oximeter EUDAMEDCONTEC FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMEDFDA UDI
- Model / Reference
- CMS50DL, CMS50D EUDAMEDCMS50DL EUDAMEDFDA UDI
- Description
- Pulse Oximeter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040100799 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401CMS50DFG EUDAMED
- Direct Marketing DI
- 06945040100799 EUDAMED
- 510(k) Number
- K082641 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
pulse oximeter by Contec Medical Systems Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69450401CMS50DFG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 5ee1c570-72e1-4aef-bb41-0d2a89d93fff 61 fields · synced Jul 25, 2026
- FDA UDI c0908f6a-78c1-458f-8ef2-c8c498fc8664 34 fields · synced May 30, 2026