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Bed Sheet/Cover

EUDAMED

Class I (EU MDR)

Ref B1011Model B1011,B1012,B1021,B1022,B1023,B1031,B1041,B1051,B1061,BR070,BR080,B2011,B2012,B2013,B2021,B2022,B2023,B2031,B2041,B2051

by Xiantao S&J Protective Products Co., Ltd

Identity

Device Name
Bed Sheet/Cover EUDAMED
Model / Reference
B1011,B1012,B1021,B1022,B1023,B1031,B1041,B1051,B1061,BR070,BR080,B2011,B2012,B2013,B2021,B2022,B2023,B2031,B2041,B2051 EUDAMED
B1011 EUDAMED

Identifiers

Primary DI / UDI-DI
06974960068506 EUDAMED
Basic UDI-DI
697496006B10119C EUDAMED
EMDN Code
T030502 BED AND STRETCHER HYGIENIC COVERS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Bed Sheet/Cover by Xiantao S&J Protective Products 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
CN-MF-000009006
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 258436c1-617e-47a3-96a3-bf5f98e3899f 61 fields · synced Jul 9, 2026