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Pneumatic Effort Belt - Size XXL

EUDAMED

Class I (EU MDR)

Ref SEN645Model Pneumatic belt

by SOMNOmedics AG

Identity

Trade Name
Pneumatic Effort Belt - Size XXL EUDAMED
Model / Reference
Pneumatic belt EUDAMED
SEN645 EUDAMED

Identifiers

Primary DI / UDI-DI
04250413402427 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 XXL 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

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Manufacturer

Manufacturer
SOMNOmedics AG
EUDAMED SRN
DE-MF-000006921

Sources (1)

  • EUDAMED f47237a0-940a-4e88-a474-69fee36df2f0 61 fields · synced Jul 9, 2026