Identity
- Device Name
- Non-Sterile Isolation Gown EUDAMED
- Model / Reference
- 1729.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08936217152213 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 (1)
- EUDAMED c78451c4-6c13-4f59-9f01-ac84ff4798aa 61 fields · synced Jun 18, 2026