Identity
- Trade Name
- Patch EUDAMED
- Device Name
- ePatch ECG Electrode EUDAMED
- Model / Reference
- 02-01640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B146PE2C1 EUDAMED
- Basic UDI-DI
- ++B146PatchElectrodeHC EUDAMED
- 510(k) Number
- K153473 FDA 510(k)
- FDA Product Code
- DSI FDA 510(k)
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Patch by Braemar Manufacturing, LLC — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — 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 (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153473 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B146PatchElectrodeHC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Braemar Manufacturing, LLC
- EUDAMED SRN
- US-MF-000036101
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 1f5deba1-2d50-4c7f-8b8a-2e7ba83205d2 61 fields · synced Jul 14, 2026
- FDA 510(k) K153473 24 fields · synced May 18, 2026