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BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey M-Size
EUDAMEDClass I (EU MDR)
Ref 0Model KE60
Identity
- Trade Name
- BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey M-Size EUDAMED
- Device Name
- BRACOO KE60 Knee Airy Sleeve Breathable & Stabilizer w/ Ergo Cushion Pad Gary XL-Size EUDAMED
- Model / Reference
- KE60 EUDAMED0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879645415 EUDAMED
- Basic UDI-DI
- 471987964KXXXVT EUDAMED
- Direct Marketing DI
- 04719879645415 EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER 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
BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey M-Size by Comfy Health Group Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 471987964KXXXVT | Class I | Active |
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Manufacturer
- Manufacturer
- Comfy Health Group Co., Ltd.
- EUDAMED SRN
- TW-MF-000047382
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4c242472-9e04-40fc-a056-5650f5ae8834 61 fields · synced Jun 17, 2026