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Alternating pressure air flotation mattress

EUDAMED

Class I (EU MDR)

Ref KE-913AHRef KE-919AHRef KE-911AHRef KE-918AW

by Paramount Bed Co., Ltd.

Identity

Trade Name
Alternating pressure air flotation mattress EUDAMED
Device Name
Alternating pressure air flotation mattress EUDAMED
Model / Reference
KE-913AH EUDAMED
KE-919AH EUDAMED
KE-911AH EUDAMED
KE-918AW EUDAMED

Identifiers

Primary DI / UDI-DI
04527799704507 EUDAMED
04527799704521 EUDAMED
04527799704491 EUDAMED
04527799703746 EUDAMED
Basic UDI-DI
4527799TD73D0120094 EUDAMED
EMDN Code
V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED

Classification

Device Class
Class I 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

Alternating pressure air flotation mattress by Paramount Bed Co., 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

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Manufacturer

EUDAMED SRN
JP-MF-000002285
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (4)

  • EUDAMED c3069e4b-163b-4447-b314-acd11f0f9333 61 fields · synced Jul 23, 2026
  • EUDAMED e9427748-bd75-4329-9ec4-8e8ba6014177 61 fields · synced May 17, 2026
  • EUDAMED 138de63f-633a-42b1-98d5-e89f14ffd166 61 fields · synced May 17, 2026
  • EUDAMED 1cdbb611-60e7-4c39-9eee-47d2cf5188bd 61 fields · synced May 18, 2026