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Gel Beads #8 - 35x11cm Wrist Pack

EUDAMED

Class I (EU MDR)

Ref AX-HP8 G03252 859990Model G03252

by Wuhan Pakcare Bio‐technology Co., Ltd.

Identity

Device Name
Gel Beads #8 - 35x11cm Wrist Pack EUDAMED
Model / Reference
G03252 EUDAMED
AX-HP8 G03252 859990 EUDAMED

Identifiers

Primary DI / UDI-DI
06973589090745 EUDAMED
Basic UDI-DI
B-06973589090745 EUDAMED
EMDN Code
M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Hot/cold therapy pack, reusable

Gel Beads #8 - 35x11cm Wrist Pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Hot/cold therapy pack, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000008960
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 2a8e8a35-3906-4f99-8aa8-315f3d3b4169 61 fields · synced Oct 5, 2026