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BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size
EUDAMEDClass I (EU MDR)
Ref 0Model KE60
Identity
- Trade Name
- BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-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
- 04719879645422 EUDAMED
- Basic UDI-DI
- 471987964KXXXVT EUDAMED
- Direct Marketing DI
- 04719879645422 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
Category: Compression/pressure sock/stocking, reusable
BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size by Comfy Health Group Co., Ltd. — Class I — MDR — listed in EUDAMED
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Also classified as Compression/pressure sock/stocking, reusable.
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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 0cfa892d-a6fc-4cd9-ba52-fd8ba3447f39 61 fields · synced Jun 18, 2026