BlueSensor SUECG Electrodes
FDA UDIEUDAMEDClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- Ambu® BlueSensor N EUDAMEDAmbu® BlueSensor L EUDAMEDBlueSensor SUECG Electrodes FDA UDIBlueSensor LECG Electrodes FDA UDIBlueSensor NECG Electrodes FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- BlueSensor Wet gel EUDAMEDECG electrodes FDA UDIECG Electrodes Wet Gel A Fitting FDA UDIECG Electrodes Wet Gel K Connector 50 cm Lead Wire FDA UDI
- Model / Reference
- L-00-A/25 EUDAMEDFDA UDIN-50-K/25 EUDAMEDFDA UDIBlueSensor Wet gel EUDAMEDSU-00-C/100 FDA UDI
- Description
- ECG electrodes FDA UDIECG Electrodes Wet Gel A Fitting FDA UDIECG Electrodes Wet Gel K Connector 50 cm Lead Wire FDA UDI
Identifiers
- Catalog Number
- SU-00-C/100 FDA UDIL-00-A/25 FDA UDIN-50-K/25 FDA UDI
- Primary DI / UDI-DI
- 05707480025718 EUDAMEDFDA UDI05707480022120 EUDAMEDFDA UDI05707480022243 FDA UDI
- Basic UDI-DI
- 5707480301005204587 EUDAMED
- Unit of Use DI
- 05707480023998 EUDAMED05707480025725 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrocardiographic electrode, single-use
BlueSensor SUECG Electrodes by Ambu A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (5)
- FDA UDI c6ccfc15-509e-4012-b5be-a34a10196a7e 36 fields · synced Aug 1, 2026
- FDA UDI faf16832-2da2-4d06-ae39-4d15e6251165 37 fields · synced May 30, 2026
- FDA UDI b42269a8-88dd-41f8-bd06-d74cb27cb3e0 37 fields · synced May 30, 2026
- EUDAMED 28df635a-a627-4eb4-a92b-cea4d3dcb43e 61 fields · synced Jul 8, 2026
- EUDAMED d2208a2c-c8cf-4c5f-8638-956c4d711475 61 fields · synced Aug 1, 2026