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ECG EKG Cable with Lead Wires
EUDAMEDClass I (EU MDR)
Ref MC049Model 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, etcRef MC150-5Ref MC065-5Ref MC148-3Ref MC153-3IG
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 EUDAMEDMC049 EUDAMEDMC150-5 EUDAMEDMC065-5 EUDAMEDMC148-3 EUDAMEDMC153-3IG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977543565539 EUDAMED06977543569872 EUDAMED06977543566208 EUDAMED06977543569865 EUDAMED06977543569889 EUDAMED
- Basic UDI-DI
- 697754356EW001LN EUDAMED
- EMDN Code
- Z1203020685 VITAL SIGNS TELEMETRY INSTRUMENTS - CONSUMABLES EUDAMEDZ12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 (5)
- EUDAMED 43ded780-8103-4c36-b48f-d85b25d636cd 61 fields · synced Jul 25, 2026
- EUDAMED 7a0f8243-e0cb-4bea-af80-be86e8ecaa4d 61 fields · synced May 17, 2026
- EUDAMED cea2236f-39db-4cac-b3b0-bcc1907ef666 61 fields · synced May 17, 2026
- EUDAMED bcf9f7f3-baff-4b4c-83e9-4c27a726b42e 61 fields · synced May 17, 2026
- EUDAMED d9f43821-4097-4268-b5d8-1f9547c434b9 61 fields · synced May 17, 2026