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Bittium MedicalSuite Mobile
EUDAMEDClass IIa (EU MDR)
Ref 9530433Model MedicalSuite Mobile v3.x
Identity
- Trade Name
- Bittium MedicalSuite Mobile EUDAMED
- Device Name
- MedicalSuite Mobile EUDAMED
- Model / Reference
- MedicalSuite Mobile v3.x EUDAMED9530433 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035221011 EUDAMED
- Basic UDI-DI
- 643003522SuiteMYW EUDAMED
- EMDN Code
- Z12050482 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Finland 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
Bittium MedicalSuite Mobile by Bittium Biosignals Ltd — 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 | 643003522SuiteMYW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED b1991ab8-07ef-48eb-99c2-92eaad1534c2 61 fields · synced Jul 15, 2026