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Surgical gown
EUDAMEDClass I (EU MDR)
Ref 97103Model Surgical gownsModel Surgical Gowns
Identity
- Trade Name
- Surgical gown EUDAMEDSurgical gown sterile EUDAMED
- Device Name
- Surgical gowns EUDAMEDStandard Surgical Gown Size L sterile EUDAMED
- Model / Reference
- Surgical gowns EUDAMED97103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288623032 EUDAMED
- Basic UDI-DI
- B-06956288623032 EUDAMED69562886AA0002FG EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDFrance 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 Cobes Industries(Hefei) Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06956288623032 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288623032 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- DISPOMED S.A.S FR-AR-000000891
Sources (2)
- EUDAMED 518a9422-0fa1-4872-9003-93e97e1611e1 61 fields · synced Oct 6, 2026
- EUDAMED db5f7319-1f26-4707-b3c8-62cae1f38573 61 fields · synced May 17, 2026