Identity
- Trade Name
- ePatch EUDAMEDePatch Electrode-patch FDA UDI
- Generic Name
- Ambulatory recorder conductive patch FDA UDI
- Device Name
- ePatch ECG Electrode EUDAMED
- Model / Reference
- 02-00168 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- B146EPE0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B146PatchElectrodeHC EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Ambulatory recorder conductive patch FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Category: Electrocardiographic electrode, single-use
ePatch by Braemar Manufacturing, LLC — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
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- 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 | K171410 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B146PatchElectrodeHC | Class I | Active |
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Manufacturer
- Manufacturer
- Braemar Manufacturing, LLC
- EUDAMED SRN
- US-MF-000036101
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED a00f17d4-b38c-4184-8351-8891eb3ce54e 61 fields · synced Jul 31, 2026
- FDA UDI 6d856fd7-5184-4b4a-8666-e257fc0fab45 32 fields · synced May 30, 2026
- FDA 510(k) K171410 1 fields · synced May 18, 2026