Identity
- Trade Name
- S&J FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- CPE Gown EUDAMED
- Model / Reference
- L6011 EUDAMEDn/a EUDAMEDG6011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974960068216 EUDAMEDFDA UDI
- Basic UDI-DI
- 697496006L6011DV EUDAMED
- FDA Product Code
- OEA FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
CPE 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 | 697496006L6011DV | 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 02caac4b-d3d0-444e-94d6-cbf126c624bb 61 fields · synced Jul 9, 2026
- FDA UDI 892df643-b07e-49b7-8c78-212100c67117 32 fields · synced May 29, 2026