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Coveralls
EUDAMEDClass I (EU MDR)
Ref S/M/L/XL/XXL/XXXLModel IsRef N/AModel S, M, L, XL,2XL,3XL,4XL,5XL
Identity
- Device Name
- Coveralls EUDAMED
- Model / Reference
- Is EUDAMEDS/M/L/XL/XXL/XXXL EUDAMEDS, M, L, XL,2XL,3XL,4XL,5XL EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063463083 EUDAMED
- Basic UDI-DI
- 697506346iscoveralls6C EUDAMEDB-06975063463083 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMEDT0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Coveralls by Xiantao Fushi Protective Products Co., Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697506346iscoveralls6C | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697506346iscoveralls6C | 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 (3)
- EUDAMED 3b899e3f-b730-4b56-9885-9d2233ccaf21 61 fields · synced Jun 18, 2026
- EUDAMED 302f5baa-d6ca-4dcb-bc07-75363fc4c5c3 61 fields · synced May 18, 2026
- EUDAMED 302f5baa-d6ca-4dcb-bc07-75363fc4c5c3-1 61 fields · synced Jun 9, 2026