Identity
- Trade Name
- Rampart M1128 Drape Kit (15 EA/CS) EUDAMED
- Device Name
- RAMPART M1128 DRAPE KIT (15 EA/CS) EUDAMED
- Model / Reference
- M1128-CDK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 27466532979325 EUDAMED
- Basic UDI-DI
- 746742323M1128-CDK5S EUDAMED
- Direct Marketing DI
- 27466532979325 EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Rampart M1128 Drape Kit (15 EA/CS) by Das Medical International, Srl — 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 | 746742323M1128-CDK5S | Class I | Active |
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Manufacturer
- Manufacturer
- DAS Medical International, SRL
- EUDAMED SRN
- DO-MF-000034519
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 8f1059a3-8ec1-4434-b26e-6f7efef23c3b 61 fields · synced Jun 19, 2026