Identity
- Trade Name
- Philips Holter Software EUDAMEDHolter Software FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- Holter SW EUDAMEDPhilips Holter Software w/ Zymed Alg FDA UDI
- Model / Reference
- 860292 EUDAMEDPhilips Holter Software FDA UDI
- Description
- Philips Holter Software w/ Zymed Alg FDA UDI
Identifiers
- Catalog Number
- 860292 FDA UDI
- Primary DI / UDI-DI
- 00884838094895 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838094895 EUDAMED
- FDA Product Code
- MLO FDA UDI
- EMDN Code
- Z12050482 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Philips Holter Software 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-00884838094895 | 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 Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 7ec05704-a435-4d63-bfaf-68b9f5f326bd 61 fields · synced Jul 25, 2026
- FDA UDI 348fb4db-86f7-4341-8ae3-7bf983e0d9dd 35 fields · synced May 30, 2026