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Foliodress® Care Gown Standard size XXL
EUDAMEDClass I (EU MDR)
Ref 992043Model Isolation Gowns
Identity
- Trade Name
- Foliodress® Care Gown Standard size XXL EUDAMED
- Device Name
- Isolation Gowns EUDAMED
- Model / Reference
- Isolation Gowns EUDAMED992043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18834000177023 EUDAMED
- Basic UDI-DI
- 8834000177DA0001ME EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Foliodress® Care Gown Standard size XXL by Cobes Industries (bago) Company Limited — 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 | 8834000177DA0001ME | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries (bago) Company Limited
- EUDAMED SRN
- MM-MF-000012366
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b368bcde-b23d-4178-b5d3-cce02059c428 61 fields · synced Jun 18, 2026