Identity
- Trade Name
- Google ECG app EUDAMED
- Device Name
- Google ECG App EUDAMED
- Model / Reference
- GA13098 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810028737815 EUDAMED
- Basic UDI-DI
- 081003885FB603R8 EUDAMED
- Direct Marketing DI
- 00810028737815 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Google ECG app by Fitbit LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003885FB603R8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fitbit LLC
- EUDAMED SRN
- US-MF-000007439
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED eb4262dc-1eab-4095-9777-16deb0d24e67 61 fields · synced Sep 18, 2026