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Gel Beads #1 - 11x27cm Multi-Zone
EUDAMEDClass I (EU MDR)
Ref AX-HP1 G03245 859983Model G03245
Identity
- Device Name
- Gel Beads #1 - 11x27cm Multi-Zone EUDAMED
- Model / Reference
- G03245 EUDAMEDAX-HP1 G03245 859983 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589090691 EUDAMED
- Basic UDI-DI
- B-06973589090691 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 #1 - 11x27cm Multi-Zone 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-06973589090691 | 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 a3346395-99c6-48a5-a418-05685c530a03 61 fields · synced Jun 19, 2026