Identity
- Trade Name
- S&J FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- S5011 EUDAMEDFDA UDIn/a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974960065017 EUDAMEDFDA UDI
- Basic UDI-DI
- 697496006S5011G3 EUDAMED
- FDA Product Code
- LYU FDA UDI
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Surgical Gown by Xiantao S&J Protective Products Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697496006S5011G3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Xiantao S&J Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009006
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ee38731f-7145-4bc0-8586-2b8df1418b19 61 fields · synced Jul 9, 2026
- FDA UDI 97dfe436-1aac-4338-8798-a746646ac229 32 fields · synced May 30, 2026