Identity
- Device Name
- Non-woven Gown EUDAMED
- Model / Reference
- FY1610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977206051645 EUDAMED
- Basic UDI-DI
- 697720605Gown01AD EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Non-woven Gown by Ningbo Foyomed Medical Instruments 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 | 697720605Gown01AD | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Foyomed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032266
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 119e4d04-9ece-42b7-a2cc-7cc94423c162 61 fields · synced Oct 6, 2026