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Heat Wraps
EUDAMEDClass IIa (EU MDR)
Ref 4260150789934Model KK-IW-N 45Ref 4260150789910Ref KK-IW-N45ARef 4260150789958Ref KK-IW-W45Ref 4260150789811Ref 4260150789835Ref WP0044Ref WP0028Ref WP0043Ref WP0040
Identity
- Device Name
- Heat Wraps EUDAMED
- Model / Reference
- KK-IW-N 45 EUDAMED4260150789934 EUDAMED4260150789910 EUDAMEDKK-IW-N45A EUDAMED4260150789958 EUDAMEDKK-IW-W45 EUDAMED4260150789811 EUDAMED4260150789835 EUDAMEDWP0044 EUDAMEDWP0028 EUDAMEDWP0043 EUDAMEDWP0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974423593071 EUDAMED06974423593064 EUDAMED06974423593026 EUDAMED06974423593057 EUDAMED06974423592906 EUDAMED06974423593033 EUDAMED06974423593040 EUDAMED06974423593309 EUDAMED06974423593866 EUDAMED06974423593644 EUDAMED06974423593583 EUDAMED
- Basic UDI-DI
- 697442359IWN45P6 EUDAMED
- Direct Marketing DI
- 06974423592906 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMEDM04010201 NON-WOVEN FIXING DRESSINGS 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
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
Heat Wraps by Koolcare Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (11)
- EUDAMED 8290505f-d219-495c-bb00-0a9d3e332539 61 fields · synced Aug 1, 2026
- EUDAMED b454452e-ac0d-4ba8-b4f3-a7fed3afc6e9 61 fields · synced May 17, 2026
- EUDAMED 391994a7-2fdf-40d0-9763-5f9fd3cf5538 61 fields · synced May 17, 2026
- EUDAMED fb76a010-121d-4321-9708-8558f68178ad 61 fields · synced May 17, 2026
- EUDAMED 5eb26717-78cf-4aa2-a1af-606d674eac54 61 fields · synced May 18, 2026
- EUDAMED 55143be3-05c7-4ebf-9c78-2fda70b654c8 61 fields · synced May 18, 2026
- EUDAMED 84ac55bf-5643-459f-8fbf-e2344d0a1ae5 61 fields · synced May 18, 2026
- EUDAMED 08b22081-9333-4450-81ad-b735a0aec750 61 fields · synced Jul 10, 2026
- EUDAMED 92dc014c-0703-4782-bcf3-9b14d6275cce 61 fields · synced Jul 10, 2026
- EUDAMED 2a9d62a4-7435-4617-8a50-c829e916bb99 61 fields · synced Jul 16, 2026
- EUDAMED 45e01a98-9f5b-4c39-a502-6642734f1960 61 fields · synced Jul 22, 2026