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Standard plus surgical gown, size L
EUDAMEDClass I (EU MDR)
Ref 385206Model Surgical Gowns
Identity
- Trade Name
- Standard plus surgical gown, size L EUDAMED
- Device Name
- Standard Surgical Gown Size L sterile EUDAMED
- Model / Reference
- Surgical Gowns EUDAMED385206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288623575 EUDAMED
- Basic UDI-DI
- 69562886AA0002FG EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Standard plus surgical gown, size L by Cobes Industries(Hefei) Co., Ltd — 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 | 69562886AA0002FG | 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 (1)
- EUDAMED 80002d68-7800-48f6-9d25-1639fa90c3b3 61 fields · synced Jul 15, 2026