Identity
- Trade Name
- Isolation gown EUDAMED
- Device Name
- Isolation gown EUDAMED
- Model / Reference
- I EUDAMED50010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972370768948 EUDAMED
- Basic UDI-DI
- 6972370764300000NP 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
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
Isolation gown by Shaoxing Yibon Medical 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 | 6972370764300000NP | Class I | Active |
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Manufacturer
- Manufacturer
- Shaoxing Yibon Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000003378
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 687f248b-6b13-489c-a7eb-c8415c51c145 61 fields · synced Jun 19, 2026