Identity
- Trade Name
- Vitalis EUDAMED
- Device Name
- Heat Wraps EUDAMEDVitalis EUDAMED
- Model / Reference
- KK-IW-N 45 EUDAMEDWP0014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974423590094 EUDAMED
- Basic UDI-DI
- 697442359IWN45P6 EUDAMEDB-06974423590094 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
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vitalis by Koolcare Technology Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697442359IWN45P6 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697442359IWN45P6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Koolcare Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017687
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 3f9021c8-3f9a-4c06-b1fc-7b1a7ab929bb 61 fields · synced Jul 25, 2026
- EUDAMED ee6973a7-7f1a-4592-aa69-ae2917d06ab6 61 fields · synced May 19, 2026