← Back to catalogue
Medpex
EUDAMEDClass I (EU MDR)
Ref M36Model B3643Ref MP43CModel B4346RRef MP40Model B3240Ref MP32Model B3238
Identity
- Trade Name
- MEDPEX EUDAMED
- Device Name
- ECG ELECTRODE EUDAMED
- Model / Reference
- B3643 EUDAMEDM36 EUDAMEDB4346R EUDAMEDMP43C EUDAMEDB3240 EUDAMEDMP40 EUDAMEDB3238 EUDAMEDMP32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974081783647 EUDAMED06974081784361 EUDAMED06974081783241 EUDAMED06974081783289 EUDAMED
- Basic UDI-DI
- 697408178B36439J EUDAMED697408178B4346R6W EUDAMED697408178B32408Q EUDAMED697408178B323895 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I 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 electrode, single-use
Medpex by Bss Medical Supply Co., Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
- Elektrody EKG — SORIMEX sp. z o.o. · Class I
- ECG — Zoll Medical Corporation · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, 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 | 697408178B36439J | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bss Medical Supply Co., Limited
- EUDAMED SRN
- CN-MF-000033301
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED b977c329-d425-4782-8204-ce9db7935f83 61 fields · synced Jul 26, 2026
- EUDAMED ea4aaef9-5d20-41f6-a82b-23428422a086 61 fields · synced May 17, 2026
- EUDAMED 5d31329e-48d8-41bb-9e14-fd402909d0b8 61 fields · synced May 17, 2026
- EUDAMED 07a0ce0f-9124-4d01-9093-2cb48729eb7a 61 fields · synced May 17, 2026