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Reusable EKG / ECG Leadwire
EUDAMEDClass I (EU MDR)
Ref HL01-07
by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- Reusable EKG / ECG Leadwire EUDAMED
- Device Name
- Reusable EKG / ECG Leadwire EUDAMED
- Model / Reference
- HL01-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698870330994 EUDAMED
- Basic UDI-DI
- 86988703FMTEKGECGLEADR7 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electrocardiographic lead set, reusable
Reusable EKG / ECG Leadwire by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇ — Class I — MDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 86988703FMTEKGECGLEADR7 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022486
Sources (1)
- EUDAMED 96c419f6-709a-4367-a2af-c0ff4fd85a59 61 fields · synced Jul 12, 2026