Identity
- Trade Name
- ILR ECG Analyzer FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- ILR ECG Analyzer EUDAMED
- Model / Reference
- IM007 EUDAMEDV1.1.4 FDA UDI
Identifiers
- Catalog Number
- IM007 FDA UDI
- Primary DI / UDI-DI
- 03770025266008 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03770025266008 EUDAMED
- 510(k) Number
- K210543 FDA UDI
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Special Device Type
- -1192 EUDAMED
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ILR ECG Analyzer by Implicity — Class I — 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-03770025266008 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Implicity
- EUDAMED SRN
- FR-MF-000014184
Sources (2)
- EUDAMED 3b1ba9ec-bf67-4567-9c99-0d787aa91a63 61 fields · synced Jun 18, 2026
- FDA UDI 4169ecbf-8964-4bcd-b7a7-1c8f40ba2979 34 fields · synced May 30, 2026