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Lifecard Cf Digital Holter Mon
EUDAMEDFDA UDIClass I (EU MDR)
Ref LCFModel Lifecard
Identity
- Trade Name
- LIFECARD CF DIGITAL HOLTER MON EUDAMEDLifecard FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Lifecard EUDAMED90 MB COMPACT FLASH CARD FDA UDI
- Model / Reference
- Lifecard EUDAMEDLCF EUDAMEDCompact Flash Card FDA UDI
- Description
- 90 MB COMPACT FLASH CARD FDA UDI
Identifiers
- Catalog Number
- CFC90MB FDA UDI
- Primary DI / UDI-DI
- 10841522131097 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221ICFCLCFOEM8P EUDAMED
- Direct Marketing DI
- 10841522131097 EUDAMED
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050404 BLOOD PRESSURE HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- France 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lifecard Cf Digital Holter Mon by Spacelabs Healthcare Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415221ICFCLCFOEM8P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- EUDAMED SRN
- GB-MF-000001196
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED b08e24a8-ccc9-4b8d-a42e-848b783aa1d7 61 fields · synced Jun 18, 2026
- FDA UDI d9b47b11-d90a-46ed-adad-cc3957b81b46 34 fields · synced May 30, 2026