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ECG EKG Cable with Lead Wires
EUDAMEDClass I (EU MDR)
Ref MC001-5IGModel MC001-3AG, MC001-3AS, MC001-5IG, MC001-5IS, MC001-3IG, MC001-3IS, MC005-5AG, MC005-5AS, MC001A-3, MC001A-5, MC001A-SM-3, MC001B-3, MC001B-5, MC002A-3, MC002A-3-1M, MC002B-3, MC002B-3A-H, MC002C-3, MC002D-3, MC003A-5, MC003B-5, MC003B-5-GE, MC003C-5, etc
Identity
- Device Name
- ECG EKG Cable with Lead Wires EUDAMED
- Model / Reference
- MC001-3AG, MC001-3AS, MC001-5IG, MC001-5IS, MC001-3IG, MC001-3IS, MC005-5AG, MC005-5AS, MC001A-3, MC001A-5, MC001A-SM-3, MC001B-3, MC001B-5, MC002A-3, MC002A-3-1M, MC002B-3, MC002B-3A-H, MC002C-3, MC002D-3, MC003A-5, MC003B-5, MC003B-5-GE, MC003C-5, etc EUDAMEDMC001-5IG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977543564204 EUDAMED
- Basic UDI-DI
- 697754356EW001LN EUDAMED
- EMDN Code
- Z12030680 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
ECG EKG Cable with Lead Wires by Hunan Greatmade Medical Tech Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697754356EW001LN | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Greatmade Medical Tech Limited
- EUDAMED SRN
- CN-MF-000042754
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3ba41837-b522-4895-9a75-85f7d7f1d092 61 fields · synced Jun 18, 2026