Identity
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- S, M, L, XL, XXL, XXXL, XXXXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975382070115 EUDAMED
- Basic UDI-DI
- 697538207SG001J9 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 Xinyang Yihe Non-woven 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 | 697538207SG001J9 | Class I | Active |
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Manufacturer
- Manufacturer
- Xinyang Yihe Non-Woven Co., Ltd
- EUDAMED SRN
- CN-MF-000023918
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED e48b7d8c-c5c6-4545-85c7-9d500f8323f4 61 fields · synced Oct 6, 2026
- EUDAMED e48b7d8c-c5c6-4545-85c7-9d500f8323f4-1 61 fields · synced Jun 10, 2026