Multi-LinkTM X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, I…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Multi-LinkTM X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, IEC, 3.6 m/12 ft EUDAMEDMulti-Link™ FDA UDI
- Generic Name
- Electrocardiographic lead set, single-use FDA UDI
- Device Name
- Multi-Link™ X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, IEC, 3.6 m/12 ft FDA UDI
- Model / Reference
- Multi-Link X2 Single-Patient-Use Long ECG Leadwire Sets EUDAMED2086367-005 EUDAMEDFDA UDI
- Description
- Multi-Link™ X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, IEC, 3.6 m/12 ft FDA UDI
Identifiers
- Catalog Number
- 2086367-005 FDA UDI
- Primary DI / UDI-DI
- 10889483577493 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041cECGmon12XT EUDAMED
- 510(k) Number
- K162432 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
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
Multi-LinkTM X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, I… by AirLife Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED a79600f3-c085-47a5-ad36-02ff533cc11f 61 fields · synced Jul 9, 2026
- FDA UDI 84b784e5-1802-43e0-96c8-76afe6576cb4 37 fields · synced May 30, 2026