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Gel Beads #6 - 30x22cm Knee Pack
EUDAMEDClass I (EU MDR)
Ref AX-HP6 G03250 859988Model B053B1
Identity
- Device Name
- Gel Beads #6 - 30x22cm Knee Pack EUDAMED
- Model / Reference
- B053B1 EUDAMEDAX-HP6 G03250 859988 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589090769 EUDAMED
- Basic UDI-DI
- B-06973589090769 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
Gel Beads #6 - 30x22cm Knee Pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06973589090769 | 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 (1)
- EUDAMED 03dbb8ab-9060-4367-85dc-479b23091a32 61 fields · synced Oct 7, 2026