Identity
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- S, M, L, XL,2XL,3XL,4XL,5XL EUDAMEDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063460303 EUDAMED
- Basic UDI-DI
- 697506346isogownQA EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Xiantao Fushi Protective 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 | 697506346isogownQA | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Fushi Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000017275
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7510ba26-87b0-4890-8e05-b7f35dedc730 61 fields · synced Jun 17, 2026