Identity
- Trade Name
- Electrode Lead 6 BR-936PA EUDAMEDElectrode Lead 6 BR-906PA EUDAMEDNA FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- General-purpose multi-parameter bedside monitor EUDAMEDElectrode lead 6, clip, AHA FDA UDIECG Electrode Lead (6 Electrodes) AHA, clip type FDA UDI
- Model / Reference
- K903D EUDAMEDK912A EUDAMEDBR-936PA FDA UDIBR-906PA FDA UDI
- Description
- Electrode lead 6, clip, AHA FDA UDIECG Electrode Lead (6 Electrodes) AHA, clip type FDA UDI
Identifiers
- Catalog Number
- BR-936PA FDA UDIBR-906PA FDA UDI
- Primary DI / UDI-DI
- 04931921902295 EUDAMEDFDA UDI04931921859735 EUDAMEDFDA UDI
- Basic UDI-DI
- 4931921MD10004BD EUDAMED
- FDA Product Code
- MHX FDA UDIDRG FDA UDIDRT 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
- 870.1025 FDA UDI870.2910 FDA UDI870.2300 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 6 BR-936PA by Nihon Kohden Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose multi-parameter bedside monitor.
- SpO2 Adapter cable — Orantech Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
- Expression MR200 Accessories — Philips DS North America LLC · Class II
- IBP Adapter Cable — Orantech Inc. · Class I
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (4)
- EUDAMED b437c78e-bb03-487c-9749-b878406653a3 61 fields · synced Jul 15, 2026
- FDA UDI 722f5287-4af4-4fcb-9e4e-d05b068ad6f3 35 fields · synced May 29, 2026
- FDA UDI abe96c14-fc3b-4436-9b48-9a61d9420bcd 35 fields · synced May 30, 2026
- EUDAMED b7611766-e6a0-4237-8b4a-5617989c3d85 61 fields · synced Jul 15, 2026