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Night Splint
EUDAMEDClass I (EU MDR)
Ref FG-1002-1Model FG-1002-1-SModel FG-1002-1-L
Identity
- Device Name
- Night Splint EUDAMED
- Model / Reference
- FG-1002-1-S EUDAMEDFG-1002-1 EUDAMEDFG-1002-1-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976009951220 EUDAMED06976009953743 EUDAMED
- Basic UDI-DI
- 6976009951220CA EUDAMED6976009953743DV EUDAMED
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Night Splint 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 | 6976009951220CA | 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 2310ab3b-5d7e-478c-a43f-cc215b5400f8 61 fields · synced Oct 6, 2026
- EUDAMED 4e9a1456-7dab-4a77-9c22-704fc260df1c 61 fields · synced May 16, 2026