Multi-Link™ ECG Leadwire, Individual Replacement, White RA, Snap, AHA, 130 cm/51 in
Ref 412596-102
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0190752TDHEL133P4 10190752180369 | Date15 Dec 2021 | StatusActive |
| United States | GUDID listing GUDID | Number10190752180369 | Date15 Dec 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Multi-Link™ ECG Leadwire, Individual Replacement, White RA, Snap, AHA, 130 cm/51 in EUDAMEDMulti-Link™ GUDID
- Generic Name
- Electrocardiographic lead set, reusable
- Device Name
- Multi-Link™ ECG Leadwire, Individual Replacement
- Model / Ref / Catalog
- 412596-102
- Primary DI / UDI-DI
- 10190752180369
- Basic UDI-DI
- 0190752TDHEL133P4
- Direct Marketing DI
- 10190752180369
- FDA Product Code
- DSA
- EMDN Code
- Z12050380 Electrocardiographs - hardware accessories
- GMDN Term
- Electrocardiographic lead set, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.2900
- EU market of registration
- Finland
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- FI-MF-000001482
Other devices from AirLife Finland Oy
Properties
Other properties (21)
- 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: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No