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Google Irregular Rhythm Notifications
EUDAMEDClass IIa (EU MDR)
Ref GA13099Model FB604
by Fitbit LLC
Identity
- Trade Name
- Google Irregular Rhythm Notifications EUDAMED
- Device Name
- Fitbit Irregular Rhythm Notifications EUDAMED
- Model / Reference
- FB604 EUDAMEDGA13099 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810028737778 EUDAMED
- Basic UDI-DI
- 081003885FB604RA EUDAMED
- Direct Marketing DI
- 00810028737778 EUDAMED
- EMDN Code
- Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES 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 Irregular Rhythm Notifications 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 | 081003885FB604RA | 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 a1fcec03-c3ec-4ff8-9349-e35e56585c12 61 fields · synced Jul 14, 2026