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Knee Brace
EUDAMEDClass I (EU MDR)
Ref FG-K038 UModel FG-1158,FG-9001,FG-9004,FG-9010,FG-9027,FG-9029,FG-9035,FG-9037,FG-9037-1,FG-9050,FG-9053,FG-9053-1,FG-9065,FG-9069,FG-PED003,FG-PED023,FG-PED024, etc.
Identity
- Device Name
- Knee Brace EUDAMED
- Model / Reference
- FG-1158,FG-9001,FG-9004,FG-9010,FG-9027,FG-9029,FG-9035,FG-9037,FG-9037-1,FG-9050,FG-9053,FG-9053-1,FG-9065,FG-9069,FG-PED003,FG-PED023,FG-PED024, etc. EUDAMEDFG-K038 U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976009959042 EUDAMED
- Basic UDI-DI
- 697600995KB001F2 EUDAMED
- EMDN Code
- Y090618 LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
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 | 697600995KB001F2 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen LongStar Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000034315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a8bb3246-b778-4508-97b5-f92a7fadb833 61 fields · synced Oct 8, 2026