← Back to catalogue
ePatch 2.5 Sensor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 02-02046Model ePatch 2.5
Identity
- Trade Name
- ePatch 2.5 Sensor EUDAMEDePatch 2.5, BTI FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- ePatch 2.5 ECG Recorder EUDAMED
- Model / Reference
- ePatch 2.5 EUDAMED02-02046 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- B146EP2520 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B146EP2520 EUDAMED
- 510(k) Number
- K171410 FDA UDI
- FDA Product Code
- DSH FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
ePatch 2.5 Sensor by Braemar Manufacturing, LLC — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-B146EP2520 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-B146EP2520 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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 937455e8-934c-4797-9c72-6bab276e4cfb 61 fields · synced Jul 13, 2026
- FDA UDI ad2b58c4-cf59-4876-a833-0d83d979bc36 33 fields · synced May 25, 2026