Disposable Gown Without Sleeves

by HanChuan Tengfei Plastic Products Co., Ltd. 4 variants

Ref 50x80cmModel 110x140cm/65x115cm/60x110cm/98×130cm/50x80cm，or customized

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697925149DGWS001ZF Basic UDI-DI 06979251490134UDI-DI	Date7 Nov 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: 110x140cm/65x115cm/60x110cm/98×130cm/50x80cm，or customized, 50x80cm

Primary DI / UDI-DI: 06979251490134
Basic UDI-DI: 697925149DGWS001ZF
EMDN Code: T0299 Protection drapes and garments - other

Device Class: Class I
EU market of registration: France

Manufacturer details

EUDAMED SRN: CN-MF-000039398
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Disposable Gown Without Sleeves

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Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No