Identity
- Trade Name
- Disposable Level 4 Gown EUDAMED
- Device Name
- Disposable Level 4 Gown EUDAMED
- Model / Reference
- IL-4036YKTP-UN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710415369086 EUDAMED
- Basic UDI-DI
- 5745001204IL4036YKTPUN7J EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Disposable Level 4 Gown by Medtecs (Cambodia) Corp, 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 | 5745001204IL4036YKTPUN7J | Class I | Active |
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Manufacturer
- Manufacturer
- Medtecs (Cambodia) Corp, Ltd.
- EUDAMED SRN
- KH-MF-000029845
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED e70981f3-9c83-4b04-97eb-1a5dcf86c4fd 61 fields · synced Jun 18, 2026