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Multi-LinkTM Single-Patient-Use ECG Leadwire Set 6-LEAD, SNAP, AHA, 100 cm/39 in
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2086349-003Model Multi-Link Single-Patient-Use ECG Leadwire Sets
Identity
- Trade Name
- Multi-LinkTM Single-Patient-Use ECG Leadwire Set 6-LEAD, SNAP, AHA, 100 cm/39 in EUDAMEDMulti-Link™ FDA UDI
- Generic Name
- Electrocardiographic lead set, single-use FDA UDI
- Device Name
- Multi-Link™ Single-Patient-Use ECG Leadwire Set 6-LEAD, SNAP, AHA, 100 cm/39 in FDA UDI
- Model / Reference
- Multi-Link Single-Patient-Use ECG Leadwire Sets EUDAMED2086349-003 EUDAMEDFDA UDI
- Description
- Multi-Link™ Single-Patient-Use ECG Leadwire Set 6-LEAD, SNAP, AHA, 100 cm/39 in FDA UDI
Identifiers
- Catalog Number
- 2086349-003 FDA UDI
- Primary DI / UDI-DI
- 10889483577448 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041cECGmon11XR EUDAMED
- 510(k) Number
- K101660 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 Single-Patient-Use ECG Leadwire Set 6-LEAD, SNAP, AHA, 100 cm/39 in 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 | 088948320041cECGmon11XR | 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 e6e465e4-20fb-4d89-9132-537838cb93e4 61 fields · synced Oct 7, 2026
- FDA UDI 900acd6a-34db-4ecf-954c-90e75fe9eb9e 37 fields · synced May 30, 2026