Identity
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- S, M, L, XL,2XL,3XL,4XL,5XL EUDAMEDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063460709 EUDAMED
- Basic UDI-DI
- 697506346surgownXF EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS 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
Surgical 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 | 697506346surgownXF | 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 40b1b9a0-4250-400e-9354-d8fd10dd55f0 61 fields · synced Jul 14, 2026