Identity
- Trade Name
- Electrode Lead 3 BR-933PA EUDAMEDNA FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- General-purpose multi-parameter bedside monitor EUDAMEDElectrode lead 3, clip, AHA FDA UDI
- Model / Reference
- K903P EUDAMEDBR-933PA FDA UDI
- Description
- Electrode lead 3, clip, AHA FDA UDI
Identifiers
- Catalog Number
- BR-933PA FDA UDI
- Primary DI / UDI-DI
- 04931921902271 EUDAMEDFDA UDI
- Basic UDI-DI
- 4931921MD10004BD EUDAMED
- FDA Product Code
- DRG FDA UDIMHX FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.1025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose multi-parameter bedside monitor
Electrode Lead 3 BR-933PA by Nihon Kohden Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4931921MD10004BD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (2)
- EUDAMED ccc03b5b-0ed7-4ac1-9a6b-03f962b76cf7 61 fields · synced Jun 18, 2026
- FDA UDI 25ded7dc-5b74-4d23-8002-bd295cdd1db9 35 fields · synced May 30, 2026