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Non-Sterile Surgical Gown
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 1996.13Model Standard Style
Identity
- Device Name
- Non-Sterile Surgical Gown EUDAMED
- Model / Reference
- Standard Style EUDAMED1996.13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08936217151834 EUDAMED
- Basic UDI-DI
- 893621715n-sterileSGownKF EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS 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 Surgical Gown by Allmed Medical Textile Co., Ltd (viet Nam) — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221637 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 893621715n-sterileSGownKF | 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 (2)
- EUDAMED 9a1d5883-d42a-4c0d-bfad-337e052b5e06 61 fields · synced Oct 7, 2026
- FDA 510(k) K221637 1 fields · synced May 18, 2026