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Surgical gown sterile
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref VO41XLModel Surgical gowns
Identity
- Trade Name
- Surgical gown sterile EUDAMEDSurgical gown EUDAMED
- Device Name
- Surgical gowns EUDAMEDSurgical gown EUDAMED
- Model / Reference
- Surgical gowns EUDAMEDVO41XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288623018 EUDAMED
- Basic UDI-DI
- 69562886AA0001FE EUDAMEDB-06956288623018 EUDAMED
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 sterile by Cobes Industries(Hefei) Co., Ltd — Class I — FDA_510K, MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141606 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886AA0001FE | Class I | Active |
| EUDAMED | European Union | CE/MDD | 69562886AA0001FE | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 6ebdbb90-0412-48fc-8fa5-b3de1456236f 61 fields · synced Oct 5, 2026
- EUDAMED 01995cd7-ba12-4539-b2fb-0e65b6740bc6 61 fields · synced May 17, 2026
- FDA 510(k) K141606 1 fields · synced May 18, 2026