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Task Force® Monitor - Single-use electrodes set
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1616Model Task Force® Monitor - Single-use electrodes set
Identity
- Trade Name
- Task Force® Monitor - Single-use electrodes set EUDAMEDSet of electrodes FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Task Force® Monitor - Single-use electrodes set EUDAMEDSet of 4ECG electrodes, 3 ICG electrodes and one grounding pad FDA UDI
- Model / Reference
- Task Force® Monitor - Single-use electrodes set EUDAMED1616 EUDAMEDV1.0 FDA UDI
- Description
- Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad FDA UDI
Identifiers
- Catalog Number
- 1616 FDA UDI
- Primary DI / UDI-DI
- 09120073931948 EUDAMEDFDA UDI
- Basic UDI-DI
- 912007393TFMEL9Q EUDAMED
- 510(k) Number
- K014063 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- C900399 CARDIOVASCULAR SENSORS - OTHER EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Task Force® Monitor - Single-use electrodes set by CNSYSTEMS MEDIZINTECHNIK GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 912007393TFMEL9Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CNSystems Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000001033
Sources (2)
- EUDAMED b359e5ff-1bc1-4827-b2aa-ff992c264d46 61 fields · synced Jun 18, 2026
- FDA UDI 97701745-3fac-4b81-84d7-0c85763fb994 37 fields · synced May 30, 2026