Edan Vital Signs Monitor iM3s
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Vital Signs Monitor EUDAMEDFDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Vital Signs Monitor EUDAMED
- Model / Reference
- iM3s EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413811171 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138iM3SS2J EUDAMED
- FDA Product Code
- DQA FDA UDIFLL FDA UDIDXN FDA UDIMWI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI880.2910 FDA UDI870.1130 FDA UDI870.2300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Edan Vital Signs Monitor iM3s is a medical device designed for the measurement of patient vital signs. It functions as a clinical monitoring tool to assist healthcare professionals in tracking physiological data.
This device is classified as Class IIb and is authorized for use under FDA 510(k) and MDR regulations. It is a non-implantable, non-sterile device that does not contain animal or human tissues and is not intended for the administration of medicine.
Frequently asked questions
Is the Edan iM3s vital signs monitor sterile?
No, the device is not supplied as a sterile product according to the provided specifications.
What is the regulatory classification of the iM3s monitor?
The device is classified as a Class IIb medical device and has received a substantial equivalence decision under FDA 510(k) and MDR authorizations.
Does the iM3s monitor contain latex?
No, the specifications indicate that the device does not contain latex.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EdanUSA M3 Vital Signs Monitor, PM M3/M3A-Edan, Comprehensive Monitoring at Your Side - Edan, Edan M3A Vital Signs Monitors | Medline, M3 Vital Signs Monitor with NIBP SpO2 and Temperature - N
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083821 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K180380 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K202892 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K120144 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K131818 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K102835 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69444138iM3SS2J | Class IIb | Active |
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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 (3)
- EUDAMED 2ec1dbf4-2783-4f35-8c94-78659ccf636f 85 fields · synced Sep 18, 2026
- FDA UDI 6582080c-01c2-4301-b861-30db71b4da0d 33 fields · synced May 29, 2026
- FDA 510(k) K083821 1 fields · synced May 18, 2026