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Leadwires, Snap, 60cm, 6set, Safety, Aha Holter Code
EUDAMEDFDA UDIClass I (EU MDR)
Ref 19-7509Model Patient cables & ECG leadwires
Identity
- Trade Name
- LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE EUDAMEDSpacelabs FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Patient cables & ECG leadwires EUDAMEDLEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE FDA UDI
- Model / Reference
- Patient cables & ECG leadwires EUDAMEDFDA UDI19-7509 EUDAMED
- Description
- LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE FDA UDI
Identifiers
- Catalog Number
- 19-7509 FDA UDI
- Primary DI / UDI-DI
- 10841522125584 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IECGCABLEOWN-UKK6 EUDAMED
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050485 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Leadwires, Snap, 60cm, 6set, Safety, Aha Holter Code by Spacelabs Healthcare Ltd — 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 | 08415221IECGCABLEOWN-UKK6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- EUDAMED SRN
- GB-MF-000001196
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 801678fd-b775-498c-8a3a-ad8a86784ccd 61 fields · synced Jun 18, 2026
- FDA UDI 1e133649-9b4f-438d-957c-3c3e13a7598b 35 fields · synced May 30, 2026