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Sterile isolation gown
EUDAMEDClass I (EU MDR)
Ref HY-70003Ref HY-70002Ref HY- 70002
Identity
- Trade Name
- Sterile isolation gown EUDAMED
- Device Name
- Sterile Non-surgical gown EUDAMED
- Model / Reference
- HY-70003 EUDAMEDHY-70002 EUDAMEDHY- 70002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942495301990 EUDAMED16942495301983 EUDAMED06942495301986 EUDAMED
- Basic UDI-DI
- 697349085UMSNSG5H EUDAMED
- Direct Marketing DI
- 16942495301990 EUDAMED16942495301983 EUDAMED06942495301986 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Sterile 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 (3)
- EUDAMED 570ecf15-d8fd-4733-b972-4d6dbec1a529 61 fields · synced Oct 6, 2026
- EUDAMED b34f520d-cc40-4c71-a724-881ed448a955 61 fields · synced May 17, 2026
- EUDAMED ba572668-3555-45b9-b28e-1d56acac6bbd 61 fields · synced May 17, 2026