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Pneumatic Effort Belt - Size XS
EUDAMEDClass I (EU MDR)
Ref SEN641Model Pneumatic belt
Identity
- Trade Name
- Pneumatic Effort Belt - Size XS EUDAMED
- Model / Reference
- Pneumatic belt EUDAMEDSEN641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413402380 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 XS 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 30984ae6-f04f-46d0-a671-747fee80888e 61 fields · synced Jul 9, 2026