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Gel Beads #9 - 12.5x8cm cartoon Pack
EUDAMEDClass I (EU MDR)
Ref G03253 859991Model G03253Ref AX-HP9 G03253 859991Model C919B1
Identity
- Device Name
- Gel Beads #9 - 12.5x8cm cartoon Pack EUDAMED
- Model / Reference
- G03253 EUDAMEDG03253 859991 EUDAMEDC919B1 EUDAMEDAX-HP9 G03253 859991 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589090851 EUDAMED06973589090776 EUDAMED
- Basic UDI-DI
- B-06973589090851 EUDAMEDB-06973589090776 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 #9 - 12.5x8cm cartoon Pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- Krioboost — EURONDA S.P.A. · Class IIa
- PRONTO DOC — Eurosirel Spa · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973589090851 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 19b90dec-6c2a-4473-81da-1bc2b8630ad6 61 fields · synced Oct 6, 2026
- EUDAMED 523b9a4e-03b9-4a15-a7d7-465778a545e9 61 fields · synced May 17, 2026