Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Sterile Non-surgical gown EUDAMED
- Model / Reference
- 904.0004E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942495300408 EUDAMED
- Basic UDI-DI
- 697349085UMSNSG5H EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Isolation Gown by Unimax Medical Products Co., 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 | 697349085UMSNSG5H | Class I | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 843d2959-e0e0-4042-8e64-ac2aa790907c 61 fields · synced Jun 19, 2026