Identity
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- S, M, L, XL, XXL, XXXL or customized EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974169911023 EUDAMED
- Basic UDI-DI
- 697416991SurgicalgownQX EUDAMED
- EMDN Code
- T020402 REINFORCED 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 Xinri 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 | 697416991SurgicalgownQX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiantao Xinri Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009835
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED df09d74c-f489-4620-9279-f6f72e4c53c1 61 fields · synced Jun 9, 2026