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ECG Electrode Lead Wire
EUDAMEDClass I (EU MDR)
Ref REL5Ref REL6DRef REL6Ref REK5Ref REL5DRef REK0Ref REK3Ref REK6Ref REL3D
Identity
- Trade Name
- ECG Electrode Lead Wire EUDAMED
- Device Name
- ECG Electrode Lead Wire EUDAMED
- Model / Reference
- REL5 EUDAMEDREL6D EUDAMEDREL6 EUDAMEDREK5 EUDAMEDREL5D EUDAMEDREK0 EUDAMEDREK3 EUDAMEDREK6 EUDAMEDREL3D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16944290676112 EUDAMED06944290664792 EUDAMED16944290676129 EUDAMED16944290676051 EUDAMED06944290664785 EUDAMED16944290676082 EUDAMED16944290676037 EUDAMED16944290676068 EUDAMED06944290664778 EUDAMED
- Basic UDI-DI
- 69442906REG8 EUDAMED
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - 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
Category: Electrocardiographic lead set, reusable
ECG Electrode Lead Wire by Beijing Rongrui-Century Science & Technology Co. , Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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 | 69442906REG8 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000015303
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (9)
- EUDAMED a38b0116-d6b3-4575-bc10-ddf6dcc9c23d 61 fields · synced Oct 6, 2026
- EUDAMED 12dabd4c-1c93-411e-9cf9-98efab8909b1 61 fields · synced May 11, 2026
- EUDAMED f5f2c779-834f-4e3a-bb96-d49f501ecdb1 61 fields · synced May 16, 2026
- EUDAMED 3e43c969-c2d7-42ed-a652-e4e523a38d82 61 fields · synced May 16, 2026
- EUDAMED abfcb293-829d-4987-beba-94a3c656a65d 61 fields · synced May 17, 2026
- EUDAMED 137bc644-0579-445e-a377-e0b316a9f066 61 fields · synced May 18, 2026
- EUDAMED 13b151f3-bf71-44b5-925a-40ae9024a1f8 61 fields · synced May 18, 2026
- EUDAMED a8b1d9d2-34c1-4344-9485-63eaf62bf639 61 fields · synced May 18, 2026
- EUDAMED b7b01770-4a14-4ea4-8246-a369971cef2f 61 fields · synced May 19, 2026