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Duk-In S-Splint
EUDAMEDClass I (EU MDR)
Ref S3825Model SplintRef S3845Ref S3210Ref S3865Ref S3530Ref S3430Ref S3630
Identity
- Trade Name
- Duk-In S-Splint EUDAMED
- Device Name
- Synthetic Orthopedic Splint EUDAMED
- Model / Reference
- Splint EUDAMEDS3825 EUDAMEDS3845 EUDAMEDS3210 EUDAMEDS3865 EUDAMEDS3530 EUDAMEDS3430 EUDAMEDS3630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033701392 EUDAMED08800033701415 EUDAMED08800033701217 EUDAMED08800033701439 EUDAMED08800033701316 EUDAMED08800033701293 EUDAMED08800033701354 EUDAMED
- Basic UDI-DI
- 88000337SP100FF EUDAMED88000337SPLINT100K3 EUDAMED
- Direct Marketing DI
- 08800033701392 EUDAMED08800033701415 EUDAMED08800033701217 EUDAMED08800033701439 EUDAMED08800033701316 EUDAMED08800033701293 EUDAMED08800033701354 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
EUDAMEDEUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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 S-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 | 88000337SP100FF | 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 (7)
- EUDAMED ae944e6c-16d7-43d3-af91-1f556d3ab739 61 fields · synced Sep 18, 2026
- EUDAMED e5ff620e-a9d8-497a-991b-6548dd1bdb6b 61 fields · synced May 16, 2026
- EUDAMED 81aa2927-ef34-431c-891e-aed14e39899c 61 fields · synced May 16, 2026
- EUDAMED da095814-b713-4ae8-bc5f-7ce90573e0d8 61 fields · synced May 17, 2026
- EUDAMED 584e2fd6-1449-4cf4-b6dd-9908b026db36 61 fields · synced May 17, 2026
- EUDAMED b7ee763c-32a4-42ad-a892-e26e0d67b3c1 61 fields · synced May 18, 2026
- EUDAMED e8f41129-8f89-4e39-bdb3-f7b27833e9e6 61 fields · synced May 18, 2026