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Sterile Surgical Gown
EUDAMEDClass I (EU MDR)
Ref F934014Model Reinforced Style - Standard Performance
Identity
- Device Name
- Sterile Surgical Gown EUDAMED
- Model / Reference
- Reinforced Style - Standard Performance EUDAMEDF934014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08936217151445 EUDAMED
- Basic UDI-DI
- 893621715RSURGICALGOWNSXX EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Surgical 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 | 893621715RSURGICALGOWNSXX | 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 a82f4ab4-cd59-4596-a976-db76835fc3cc 61 fields · synced Jun 18, 2026