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Knee brace with cooling pads
EUDAMEDClass I (EU MDR)
Ref KB-17065Ref KB-17068Ref KB-17066Ref KB-17067
Identity
- Trade Name
- Knee brace with cooling pads EUDAMED
- Device Name
- Cryo‑/Thermotherapy EUDAMED
- Model / Reference
- KB-17065 EUDAMEDKB-17068 EUDAMEDKB-17066 EUDAMEDKB-17067 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052916995228 EUDAMED04052916995259 EUDAMED04052916995235 EUDAMED04052916995242 EUDAMED
- Basic UDI-DI
- 4032611WK2023BK EUDAMED
- Direct Marketing DI
- 04052916995228 EUDAMED04052916995259 EUDAMED04052916995235 EUDAMED04052916995242 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Category: Hot/cold therapy pack, reusable
Knee brace with cooling pads by Delta-Sport Handelskontor GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 | 4032611WK2023BK | Class I | Active |
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Manufacturer
- Manufacturer
- Delta-Sport Handelskontor GmbH
- EUDAMED SRN
- DE-MF-000005981
Sources (4)
- EUDAMED 4bf30f11-2209-4df1-9588-f389221514d2 61 fields · synced Jul 26, 2026
- EUDAMED 79fc5fea-2583-49a0-8344-f1e13f0ecaa9 61 fields · synced May 18, 2026
- EUDAMED fdf9e253-c184-41a6-ab05-83cb0cfa37bb 61 fields · synced May 18, 2026
- EUDAMED a00ae00e-7741-4050-ae7f-7a9f0fbda106 61 fields · synced May 19, 2026