Identity
- Trade Name
- DigiTrak XT Holter Recorder EUDAMEDDigiTrak XT FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- DigiTrak XT Recorder EUDAMEDDigiTrak XT Holter Recorder FDA UDI
- Model / Reference
- 860322 EUDAMEDDigiTrak XT Holter Recorder FDA UDI
- Description
- DigiTrak XT Holter Recorder FDA UDI
Identifiers
- Catalog Number
- 860322 FDA UDI
- Primary DI / UDI-DI
- 00884838000476 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838000476 EUDAMED
- FDA Product Code
- MWJ 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
- Austria 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
No
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
DigiTrak XT Holter Recorder by Philips Medical Systems — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838000476 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED eb65bba4-72cf-4895-b5c2-50c4537d0a0d 61 fields · synced Jul 12, 2026
- FDA UDI c41aefc6-f26f-4108-8ac6-2af341626225 36 fields · synced May 30, 2026