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Isolation Gown
EUDAMEDClass I (EU MDR)
Ref N/AModel S, M, L, XL,2XL,3XL,4XL,5XLRef S/M/LModel IsRef 2XLRef M
Identity
- Device Name
- Isolation Gown EUDAMEDIsolation gowns EUDAMED
- Model / Reference
- S, M, L, XL,2XL,3XL,4XL,5XL EUDAMEDN/A EUDAMEDIs EUDAMEDS/M/L EUDAMED2XL EUDAMEDM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063463014 EUDAMED06975063463199 EUDAMED16975063460348 EUDAMED16975063460317 EUDAMED
- Basic UDI-DI
- B-06975063463014 EUDAMED697506346isisogownXS EUDAMED697506346isogownQA 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
- Spain EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06975063463014 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06975063463014 | 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 (6)
- EUDAMED 7a52c22c-2488-4acc-b62b-77294448c9c3 61 fields · synced Sep 17, 2026
- EUDAMED 00409496-9e4f-4f1e-8ec4-d1d25d354567 61 fields · synced May 18, 2026
- EUDAMED 7a52c22c-2488-4acc-b62b-77294448c9c3-1 61 fields · synced Jun 10, 2026
- EUDAMED d53f70d3-e18a-4cfb-a250-a93e82128a5c 61 fields · synced Jul 8, 2026
- EUDAMED 2d32eeda-c787-48bc-ac51-ff5ce26e86af 61 fields · synced Jul 14, 2026
- EUDAMED a5c4311a-f61b-4910-adf9-96ed8584ce3f 61 fields · synced Jul 14, 2026