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Medtecs CoverU Disposable Isolation Gown
EUDAMEDClass I (EU MDR)
Ref IL-4063WKTP-CM
Identity
- Trade Name
- Medtecs CoverU Disposable Isolation Gown EUDAMED
- Device Name
- Disposable Isolation Gown EUDAMED
- Model / Reference
- IL-4063WKTP-CM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710415362322 EUDAMED
- Basic UDI-DI
- 471041536IL0148 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Medtecs CoverU Disposable Isolation 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 | 471041536IL0148 | 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 31391f5e-de54-431f-b30e-6f4b171b1c3e 61 fields · synced May 23, 2026