Identity
- Device Name
- Non-Sterile Isolation Gown EUDAMED
- Model / Reference
- 1729.02 EUDAMED1729.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08936217152190 EUDAMED08936217152206 EUDAMED08936217152183 EUDAMED
- Basic UDI-DI
- 893621715n-sterileIGownFZ EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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-Sterile Isolation Gown by Allmed Medical Textile Co., Ltd (viet Nam) — 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 | 893621715n-sterileIGownFZ | Class I | Active |
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Manufacturer
- Manufacturer
- Allmed Medical Textile Co., Ltd (viet Nam)
- EUDAMED SRN
- VN-MF-000033090
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 1bd654c2-6e3f-4948-9c67-beeb17669517 61 fields · synced Oct 6, 2026
- EUDAMED 36958ce3-5692-4bd9-b240-e19a1f25cbbd 61 fields · synced May 18, 2026
- EUDAMED 2224f46b-5d68-4aa3-9ca3-4924eface28a 61 fields · synced May 19, 2026