Identity
- Trade Name
- Corpuls EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECG Electrode EUDAMEDFDA UDI
- Model / Reference
- Corpuls EUDAMED1019CO EUDAMEDFDA UDI
- Description
- ECG Electrode FDA UDI
Identifiers
- Catalog Number
- 19101.19 FDA UDI
- Primary DI / UDI-DI
- 15060842920234 EUDAMEDFDA UDI
- Basic UDI-DI
- 50604419ECG-Elec7UN EUDAMED
- Unit of Use DI
- 05060842920237 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic electrode, single-use
Corpuls by Nissha Medical Technologies Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 50604419ECG-Elec7UN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Ltd
- EUDAMED SRN
- GB-MF-000012057
- Authorised Representative
- NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795
Sources (2)
- EUDAMED e250805c-dc08-4bdb-b03b-57e0e972988b 61 fields · synced Jul 26, 2026
- FDA UDI 8ca6a48f-ddd1-4d69-ba9e-75053c66a707 35 fields · synced May 30, 2026