Identity
- Trade Name
- WATERPROOF ISOLATION GOWN CAT. III T. XL EUDAMED
- Device Name
- PATIENT GOWN (SHORT SLEEVED) S EUDAMED
- Model / Reference
- 8200476 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680829213045 EUDAMED
- Basic UDI-DI
- 868082921NS0013FE EUDAMED
- Direct Marketing DI
- 08680829213045 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Waterproof Isolation Gown Cat. Iii T. Xl by Mhk Medi̇kal Teksti̇l San Ve Ti̇c.ltd.şti̇ — 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 | 868082921NS0013FE | Class I | Active |
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Manufacturer
- Manufacturer
- Mhk Medi̇kal Teksti̇l San Ve Ti̇c.ltd.şti̇
- EUDAMED SRN
- TR-MF-000018593
Sources (1)
- EUDAMED bfd6fb63-64fb-4f28-8b8b-936c41cf64b8 61 fields · synced Oct 7, 2026