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Pneumatic Effort Belt - Size M
EUDAMEDClass I (EU MDR)
Ref SEN643Model Pneumatic belt
Identity
- Trade Name
- Pneumatic Effort Belt - Size M EUDAMED
- Model / Reference
- Pneumatic belt EUDAMEDSEN643 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413402403 EUDAMED
- Basic UDI-DI
- 42504134PE-BeltBP EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Pneumatic Effort Belt - Size M by SOMNOmedics AG — 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 | 42504134PE-BeltBP | Class I | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED 743a6dbd-6f21-4e80-b6e9-50c9fd8c8f6e 61 fields · synced Jul 11, 2026