Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- MD2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975549102109 EUDAMED
- Basic UDI-DI
- 697554910103MD EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Isolation Gown by Medex International 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 | 697554910103MD | Class I | Active |
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Manufacturer
- Manufacturer
- Medex International Ltd
- EUDAMED SRN
- CN-MF-000034328
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7b8bec2b-76c4-4224-9d0c-a34a502ee7c8 61 fields · synced Jun 18, 2026