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Kosmos ECG Patient Cable – International
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P006186
by EchoNous
Identity
- Trade Name
- Kosmos ECG Patient Cable – International EUDAMEDKosmos ECG Patient Cable - International FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Device Name
- Kosmos EUDAMEDElectrocardiograph, professional, single-channel Electrocardiographic lead set, reusable FDA UDI
- Model / Reference
- P006186 EUDAMEDFDA UDI
- Description
- Electrocardiograph, professional, single-channel Electrocardiographic lead set, reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000243 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780KOSMOSWH EUDAMED
- 510(k) Number
- K193518 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Market of Registration
- Malta 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kosmos ECG Patient Cable – International by EchoNous — 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 | 93532780KOSMOSWH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- EchoNous
- EUDAMED SRN
- US-MF-000004161
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED ad0e1bc5-abcd-48ef-a93c-580eddabef9d 61 fields · synced Jul 22, 2026
- FDA UDI 2b61dd0a-bf38-41d6-be02-9002ba2b790b 34 fields · synced May 30, 2026