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Duk-In N-Splint
EUDAMEDClass I (EU MDR)
Ref S4545Model SplintRef S34415Ref S4825Ref S4835Ref S4530Ref S4210Ref S4845Ref S4645
Identity
- Trade Name
- Duk-In N-Splint EUDAMED
- Device Name
- Synthetic Orthopedic Splint EUDAMED
- Model / Reference
- Splint EUDAMEDS4545 EUDAMEDS34415 EUDAMEDS4825 EUDAMEDS4835 EUDAMEDS4530 EUDAMEDS4210 EUDAMEDS4845 EUDAMEDS4645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033701569 EUDAMED08800033701507 EUDAMED08800033701620 EUDAMED08800033701637 EUDAMED08800033701545 EUDAMED08800033701453 EUDAMED08800033701644 EUDAMED08800033701606 EUDAMED
- Basic UDI-DI
- 88000337SP200FL EUDAMED
- Direct Marketing DI
- 08800033701569 EUDAMED08800033701507 EUDAMED08800033701620 EUDAMED08800033701637 EUDAMED08800033701545 EUDAMED08800033701453 EUDAMED08800033701644 EUDAMED08800033701606 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Category: Cotton wool roll, sterile
Duk-In N-Splint by Duk-In Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 88000337SP200FL | Class I | Active |
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Manufacturer
- Manufacturer
- Duk-In Co., Ltd.
- EUDAMED SRN
- KR-MF-000026961
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (8)
- EUDAMED c389aa2e-8965-46a3-a89a-e2049baf259f 61 fields · synced Aug 1, 2026
- EUDAMED f4b2a100-6742-48f0-b8fb-991ea54fbd78 61 fields · synced May 16, 2026
- EUDAMED 8059fc37-2493-4f2d-a04a-4238df8646d8 61 fields · synced May 17, 2026
- EUDAMED e5119e03-2ceb-4e07-9a20-45f0b4dbb6b2 61 fields · synced May 17, 2026
- EUDAMED 47692e62-bad7-4f9e-9991-682c4b650cc3 61 fields · synced May 18, 2026
- EUDAMED 6b406865-9bae-4b44-8901-0907f548504d 61 fields · synced May 18, 2026
- EUDAMED 4458faf6-2a85-42d6-9fe8-4d34787f4493 61 fields · synced May 18, 2026
- EUDAMED ed67a8b0-0467-418e-bf2d-bea598b089de 61 fields · synced May 18, 2026