Ice gel mitten

EUDAMED

Class I (EU MDR)

Ref /Model ACST04Model C502B0Model AMRD01

by Wuhan Pakcare Bio‐technology Co., Ltd.

Identity

Trade Name: Ice gel mitten EUDAMED
Device Name: Ice gel mitten EUDAMED
Reusable Hot/cold packs EUDAMED
Model / Reference: ACST04 EUDAMED
/ EUDAMED
C502B0 EUDAMED
AMRD01 EUDAMED

Identifiers

Primary DI / UDI-DI: 06973589091834 EUDAMED
06978920972780 EUDAMED
Basic UDI-DI: B-06973589091834 EUDAMED
697358909HP100MD EUDAMED
697892097HP100Q6 EUDAMED
Direct Marketing DI: 06973589091834 EUDAMED
06978920972780 EUDAMED
EMDN Code: M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Ice gel mitten by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-06973589091834	Class I	Active
EUDAMED	European Union	CE/MDD	B-06973589091834	Class I	Active

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Manufacturer

Manufacturer: Wuhan Pakcare Bio‐technology Co., Ltd.
EUDAMED SRN: CN-MF-000008960
Authorised Representative: Share info GmbH DE-AR-000005132

Sources (3)

EUDAMED e5d218d4-98f8-41d9-afe1-01b014613f17 61 fields · synced Oct 6, 2026
EUDAMED 5358a3ca-1028-4f47-bd61-23dfaaedcef0 61 fields · synced May 19, 2026
EUDAMED b7a47460-a44b-4656-93bd-b22955de2c23 61 fields · synced Jul 22, 2026