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Surgical Gown
EUDAMEDClass I (EU MDR)
Ref N/AModel S, M, L, XL,2XL,3XL,4XL,5XLRef S/M/LModel Is
Identity
- Device Name
- Surgical Gown EUDAMEDSurgical gowns EUDAMED
- Model / Reference
- S, M, L, XL,2XL,3XL,4XL,5XL EUDAMEDN/A EUDAMEDIs EUDAMEDS/M/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063463052 EUDAMED
- Basic UDI-DI
- B-06975063463052 EUDAMED697506346issurgown72 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS 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
Surgical 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-06975063463052 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06975063463052 | 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 2a04caa5-11c3-4cbd-a153-19fe7e7872e3 61 fields · synced Jul 12, 2026
- EUDAMED b58d033f-c595-44e5-9036-3cfdcabc19c7 61 fields · synced May 17, 2026
- EUDAMED 2a04caa5-11c3-4cbd-a153-19fe7e7872e3-1 61 fields · synced Jun 9, 2026