Identity
- Trade Name
- Duk-In N-Splint EUDAMED
- Device Name
- Synthetic Orthopedic Splint EUDAMED
- Model / Reference
- Splint EUDAMEDS4210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033701446 EUDAMED
- Basic UDI-DI
- 88000337SPLINT200K8 EUDAMED
- Direct Marketing DI
- 08800033701446 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Duk-In N-Splint by Duk-In 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 | 88000337SPLINT200K8 | 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 (1)
- EUDAMED e1bbeff2-9d03-49c3-81bb-ddc12b3b7361 61 fields · synced Jun 18, 2026