Foliodress® Care gown SMS
by Cobes Industries (Bago) Company Limited EUDAMED
Active
Ref 992009Model Isolation Gowns
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8834000177DA0001ME | Date6 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 16 countries, as listed in EUDAMED:
- Austria
- Bulgaria
- Croatia
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
Specification
- Device Name
- Isolation Gowns
- Model / Reference
- Isolation Gowns, 992009
- Primary DI / UDI-DI
- 18834000177092
- Basic UDI-DI
- 8834000177DA0001ME
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- MM-MF-000012366
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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Properties
Show properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No