Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- grown EUDAMED
- Model / Reference
- 120*145 EUDAMEDa/0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974742162118 EUDAMED
- Basic UDI-DI
- 69747421620120145NX EUDAMED
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Isolation Gown by Farstar Medical Hubei 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 | 69747421620120145NX | Class I | Active |
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Manufacturer
- Manufacturer
- Farstar Medical Hubei Ltd.
- EUDAMED SRN
- CN-MF-000017294
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2bb83a8e-cf0b-42ec-8de1-da3598267662 61 fields · synced Aug 3, 2026