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BRACOO KE60 Knee Airy Sleeve Breathable & Stabilizer w/ Ergo Cushion Pad Gary X…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0Model KE60
Identity
- Trade Name
- BRACOO KE60 Knee Airy Sleeve Breathable & Stabilizer w/ Ergo Cushion Pad Gary XL-Size EUDAMEDComfyHealth FDA UDI
- Generic Name
- Multiple-joint lower limb orthosis FDA UDI
- Device Name
- BRACOO KE60 Knee Airy Sleeve Breathable & Stabilizer w/ Ergo Cushion Pad Gary XL-Size EUDAMEDFDA UDI
- Model / Reference
- KE60 EUDAMEDFDA UDI0 EUDAMED
- Description
- BRACOO KE60 Knee Airy Sleeve Breathable & Stabilizer w/ Ergo Cushion Pad Gary XL-Size FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879641110 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964KXXXVT EUDAMED
- Direct Marketing DI
- 04719879641110 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Multiple-joint lower limb orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BRACOO KE60 Knee Airy Sleeve Breathable & Stabilizer w/ Ergo Cushion Pad Gary X… by Comfy Health Group Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987964KXXXVT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED dfe33117-fc4f-4ba8-b0f8-ad99c3d321e2 61 fields · synced Jun 18, 2026
- FDA UDI e4b2b308-8aaa-479c-84f0-31de5e7376c9 33 fields · synced May 29, 2026