Identity
- Device Name
- Non-sterile Isolation gown EUDAMEDIsolation gown EUDAMED
- Model / Reference
- Ref EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972841173639 EUDAMED06972841173561 EUDAMED06972841173547 EUDAMED
- Basic UDI-DI
- 697284117IGE113EK EUDAMED697284117IG113DV EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMEDT0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Non-sterile Isolation gown by Zhejiang Mediunion Healthcare Group 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 | 697284117IGE113EK | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Mediunion Healthcare Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000026766
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED d43fb3cb-7baa-4d88-93f4-1a81806b76ac 61 fields · synced Oct 7, 2026
- EUDAMED 718ad747-465f-4455-9ef7-8faaac95e4ff 61 fields · synced Jun 18, 2026
- EUDAMED 87f7f7c4-376a-4cd2-99f8-255f6432070b 61 fields · synced Jul 31, 2026