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Excel Knee Brace
EUDAMEDClass I (EU MDR)
Ref 4239-R-BU-XL-1Ref 4239-R-BU-S-1Ref 4239-L-BU-M-1Ref 4239-R-BU-XS-1Ref 4239-L-BU-XL-1
Identity
- Trade Name
- Excel Knee Brace EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 4239-R-BU-XL-1 EUDAMED4239-R-BU-S-1 EUDAMED4239-L-BU-M-1 EUDAMED4239-R-BU-XS-1 EUDAMED4239-L-BU-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863694986 EUDAMED04719863694955 EUDAMED04719863694917 EUDAMED04719863694948 EUDAMED04719863694931 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Excel Knee Brace by OPPO Medical Corp. — Class I — 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 | 471986369CL102DF | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (5)
- EUDAMED c4357156-9848-4295-8de2-27a1230c52a8 61 fields · synced Oct 6, 2026
- EUDAMED c06b8079-e414-4bcf-9245-afcb19d5c308 61 fields · synced May 17, 2026
- EUDAMED 12edbd30-49bc-4789-96dc-bd3a328e95b3 61 fields · synced May 18, 2026
- EUDAMED 0846df0f-844b-4748-9e25-7d9b4f0b84fe 61 fields · synced May 18, 2026
- EUDAMED 997a28da-a41a-405b-8354-dc0acc74570d 61 fields · synced May 18, 2026