Identity
- Trade Name
- Duk-In Lite 'S' EUDAMED
- Device Name
- Synthetic Orthopedic Casting Tape EUDAMED
- Model / Reference
- Cast EUDAMEDL4124 EUDAMEDL4134 EUDAMEDL4154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033700098 EUDAMED08800033700111 EUDAMED08800033700159 EUDAMED
- Basic UDI-DI
- 88000337LITE100G2 EUDAMED
- Direct Marketing DI
- 08800033700098 EUDAMED08800033700111 EUDAMED08800033700159 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
Yes
EUDAMEDEUDAMED
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 Lite 'S' 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 | 88000337LITE100G2 | 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 6dd9c1dc-17e7-4b10-877f-22d07cd88b0f 61 fields · synced Sep 17, 2026
- EUDAMED ee9cc191-62d8-4051-92ae-347af59e77a3 61 fields · synced May 17, 2026
- EUDAMED 2a8da926-7e13-4972-92af-4d32a0d1aa5d 61 fields · synced May 18, 2026