Identity
- Trade Name
- Duk-In Cast EUDAMED
- Device Name
- Plaster of Paris Bandages EUDAMED
- Model / Reference
- Cast EUDAMEDC1033 EUDAMEDC1023 EUDAMEDC1053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809223460941 EUDAMED08809223460934 EUDAMED08809223460965 EUDAMED
- Basic UDI-DI
- 88000337CASTLD EUDAMED
- Direct Marketing DI
- 08809223460941 EUDAMED08809223460934 EUDAMED08809223460965 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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: Hand/finger splint, reusable
Duk-In Cast by Duk-In Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
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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 | 88000337CASTLD | 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 (3)
- EUDAMED e14c5a2f-b0f8-4c99-88dd-41161e173bfa 61 fields · synced Jul 19, 2026
- EUDAMED d5881fde-19e3-4fe0-8b8a-f38501316d5e 61 fields · synced May 17, 2026
- EUDAMED 96633a3a-01f4-4c73-9c28-0ecd6845c43d 61 fields · synced May 18, 2026