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Surgical Gown
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref Standard XLModel Standard M\L\XL\XXL\XXXL510(k) K211509
Identity
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- Standard M\L\XL\XXL\XXXL EUDAMEDStandard XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973888824485 EUDAMED
- Basic UDI-DI
- 697388882Surgicalgown5T EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Surgical Gown by Hubei Wanli Protective Products Co., Ltd. — 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 | K211509 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697388882Surgicalgown5T | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Wanli Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000008182
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a5071ccd-d5e8-4abe-b485-3c70cdd9f0a8 85 fields · synced Jun 18, 2026
- FDA 510(k) K211509 1 fields · synced May 18, 2026