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Respiro ECG Adapter (40pcs)
EUDAMEDClass I (EU MDR)
Ref 9404781Model Respiro Accessories
Identity
- Trade Name
- Respiro ECG Adapter (40pcs) EUDAMED
- Device Name
- Respiro Accessories EUDAMED
- Model / Reference
- Respiro Accessories EUDAMED9404781 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035221219 EUDAMED
- Basic UDI-DI
- 643003522RespiroAccLK EUDAMED
- EMDN Code
- Z129012 MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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
Respiro ECG Adapter (40pcs) by Bittium Biosignals Ltd — Class I — 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 | 643003522RespiroAccLK | Class I | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED b6ff7bd6-b9d1-4ee8-bedc-16fa3bd69c3e 61 fields · synced Jul 31, 2026