PolyEasy

by Guangzhou Tian Hong Medical Technology Co., Ltd. 32 variants

Model Air Mesh Thermoplastic Sheets &Splints

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	Number698010657TAM001CV Basic UDI-DI 06980106570185UDI-DI	Date13 Jul 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Withdrawn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: Thermoplastic sheet
Model / Reference: Air Mesh Thermoplastic Sheets &Splints

Primary DI / UDI-DI: 06980106570185
Basic UDI-DI: 698010657TAM001CV
EMDN Code: M03050299 Bandages and splints - other

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000008847
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties

Reusable

Other properties (12)

Sterile: No
Implantable: 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