Reusable Hot/Cold Pack for Children

by Wuhan Pakcare Bio‐technology Co., Ltd. 2 variants

Ref ACYZ14Model C502B0, AMRD01

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697358909HP100MD Basic UDI-DI 06978920970656UDI-DI	Date6 Jan 2023Registered	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Withdrawn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

Device Name: Reusable Hot/cold packs
Model / Reference: C502B0, ACYZ14, AMRD01

Primary DI / UDI-DI: 06978920970656
Basic UDI-DI: 697358909HP100MD, 697892097HP100Q6
Direct Marketing DI: 06978920970656
EMDN Code: M9001 Cryotherapy and thermotherapy devices

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000008960
Authorised representative: Share info GmbH DE-AR-000005132

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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