Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- IGS EUDAMEDIG001 EUDAMEDIGL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970863620070 EUDAMED06970863620094 EUDAMED
- Basic UDI-DI
- 697086362IGSTX EUDAMED697086362IGLTH EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Bero(Qingyuan) Nonwovens 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 | 697086362IGSTX | Class I | Active |
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Manufacturer
- Manufacturer
- Bero(Qingyuan) Nonwovens Co.Ltd
- EUDAMED SRN
- CN-MF-000027685
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED d8792206-21db-4c62-ba8f-f40619a2367a 61 fields · synced Jul 26, 2026
- EUDAMED 08143c2d-a1af-4ee0-ae6d-d83588e0f889 61 fields · synced May 16, 2026