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Tri-panel Immobilizer Knee Brace
EUDAMEDClass I (EU MDR)
Ref 1Model FG-9004 (L)Ref 2Model FG-9004 (S)
Identity
- Trade Name
- Tri-panel Immobilizer Knee Brace EUDAMED
- Device Name
- Tri-panel Immobilizer Knee Brace EUDAMED
- Model / Reference
- FG-9004 (L) EUDAMED1 EUDAMEDFG-9004 (S) EUDAMED2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976009954702 EUDAMED06976009954689 EUDAMED
- Basic UDI-DI
- 6976009954702DN EUDAMED6976009954689EP EUDAMED
- Direct Marketing DI
- 06976009954702 EUDAMED06976009954689 EUDAMED
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES 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
No
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
Tri-panel Immobilizer Knee Brace by Xiamen LongStar Medical Equipment Co., Ltd — 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 | 6976009954702DN | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen LongStar Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000034315
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 4d357288-c6aa-4000-86a3-0078b7dfe7e9 61 fields · synced Oct 6, 2026
- EUDAMED 998d9bb1-2b55-40f7-ac1e-523015213af4 61 fields · synced May 19, 2026