Disposable Medical Isolation Gown

by Henan Tuoren Medical Healthcare Products Co., Ltd. 6 variants

Ref IGG2

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697286820922PD Basic UDI-DI	Date2 Jun 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Disposable Medical Isolation Gown
Model / Reference: IGG2

Primary DI / UDI-DI: 06972868209229, 16972868209226
Basic UDI-DI: 697286820922PD, 697286820142NB
EMDN Code: T0205 Non-surgical gowns (excluding personal protective equipment - PPE)

Device Class: Class I
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000027709
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from Henan Tuoren Medical Healthcare Products Co., Ltd.

Surgical Gown

Class I
Disposable Medical Isolation Gown

Class I
Medical cap

Class I
Medical Face Mask

Class I
Surgical Gown

Class I
Disposable Medical Isolation Gown

Class I

See all devices from Henan Tuoren Medical Healthcare Products Co., Ltd. →

Properties

Sterile

Other properties (12)

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