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Multi-LinkTM X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 5-…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2090101-512Model Multi-Link X2 Single-Patient-Use Long ECG Leadwire Sets
Identity
- Trade Name
- Multi-LinkTM X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 5-Lead Set for Philips, Grabber, AHA EUDAMEDMulti-Link™ FDA UDI
- Generic Name
- Electrocardiographic lead set, single-use FDA UDI
- Device Name
- Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 5-Lead Set for Philips, Grabber, AHA FDA UDI
- Model / Reference
- Multi-Link X2 Single-Patient-Use Long ECG Leadwire Sets EUDAMED2090101-512 EUDAMEDFDA UDI
- Description
- Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 5-Lead Set for Philips, Grabber, AHA FDA UDI
Identifiers
- Catalog Number
- 2090101-512 FDA UDI
- Primary DI / UDI-DI
- 10889483577912 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041cECGmon12XT EUDAMED
- 510(k) Number
- K163316 FDA UDI
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Finland 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Multi-LinkTM X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 5-… by AirLife Finland Oy — 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 | 088948320041cECGmon12XT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED 72e2fdd7-6627-45a9-afa4-c44a9da892a7 61 fields · synced Jun 18, 2026
- FDA UDI ffad1f1e-4440-42c5-aad1-d557aec98a6d 37 fields · synced May 29, 2026