Identity
- Device Name
- Patient Suit EUDAMED
- Model / Reference
- S, M, L, XL, XXL, XXXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975382070153 EUDAMED
- Basic UDI-DI
- 697538207PS001KU EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
Patient Suit 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 | 697538207PS001KU | 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 4e4e5fe7-5159-409f-910d-05b031f91b7b 61 fields · synced Jun 19, 2026
- EUDAMED 4e4e5fe7-5159-409f-910d-05b031f91b7b-1 61 fields · synced Jun 9, 2026