Identity
- Trade Name
- DONJOY Instant Cold Pack EUDAMED
- Model / Reference
- 15AXP2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00064317150025 EUDAMED
- Basic UDI-DI
- B-00064317150025 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
DONJOY Instant Cold Pack by Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd — Class IIa — 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-00064317150025 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000007052
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7b0639bd-0540-479b-8a06-29191569c096 61 fields · synced Jun 18, 2026