← Back to catalogue
Gel Beads #2 - 10x15cm Multi-Zone
EUDAMEDClass I (EU MDR)
Ref AX-HP2 G03246 859984Model G03246
Identity
- Device Name
- Gel Beads #2 - 10x15cm Multi-Zone EUDAMED
- Model / Reference
- G03246 EUDAMEDAX-HP2 G03246 859984 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589090707 EUDAMED
- Basic UDI-DI
- B-06973589090707 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 #2 - 10x15cm Multi-Zone 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.
- Future Generation Medical — Global International L. L. C. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- ACCU-THERM — Medline Industries, LP · Class I
- Krioboost — EURONDA S.P.A. · Class IIa
- PRONTO DOC — Eurosirel Spa · Class IIa
- Kit de cryothérapie périnéale règles douloureuses — ORTHOMEDICA · Class I
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-06973589090707 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 19569aeb-6614-4095-8015-6e37191a2774 61 fields · synced Jul 10, 2026