Identity
- Trade Name
- Duk-In S-Splint EUDAMED
- Device Name
- Synthetic Orthopedic Splint EUDAMED
- Model / Reference
- Splint EUDAMEDS4312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033701231 EUDAMED
- Basic UDI-DI
- 88000337SP100FF EUDAMED
- Direct Marketing DI
- 08800033701231 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 S-Splint by Duk-In Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cotton wool roll, sterile.
- Medical Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- Delta-Dry® — BSN MEDICAL, INC. · Class I
- JERSEY TUBULAIRE HYDROFUGE 25cm x 25m — MAILL'TUB · Class I
- Rolyan Sof-Stretch Extension Splint, White, X-Small, 1/EA — Performance Health Supply, LLC · Class I
- Tricofix® — BSN MEDICAL, INC. · Class I
- Delta-Lite® Plus — BSN MEDICAL, INC. · Class I
- NOBACAST®-GRÜN 7, 5 CM 3, 6M — NOBAMED Paul Danz AG · Class I
- ROLYAN THERMOPLASTIC SHEET — Performance Health Supply, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Duk-In Co., Ltd.
- EUDAMED SRN
- KR-MF-000026961
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e8fb0ac6-f0cb-4300-a568-fb7f4cdb0423 61 fields · synced Jun 19, 2026