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Bittium MedicalSuite Center
EUDAMEDClass IIa (EU MDR)
Ref S0000022661Model MedicalSuite Center v3.x
Identity
- Trade Name
- Bittium MedicalSuite Center EUDAMED
- Device Name
- MedicalSuite Center EUDAMED
- Model / Reference
- MedicalSuite Center v3.x EUDAMEDS0000022661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035221028 EUDAMED
- Basic UDI-DI
- 643003522SuiteCYA EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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 Center 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 | 643003522SuiteCYA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED e6906bc1-3ee1-45c7-a5ef-d8cd07386490 61 fields · synced Jul 9, 2026