Identity
- Trade Name
- Rampart M1128 Drape Kit EUDAMEDRampart FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- RAMPART M1128 DRAPE KIT (15 EA/CS) EUDAMEDRAMPART M1128 DRAPE KIT (M1128-CDK) FDA UDI
- Model / Reference
- M1128-CDK EUDAMEDFDA UDI
- Description
- RAMPART M1128 DRAPE KIT (M1128-CDK) FDA UDI
Identifiers
- Catalog Number
- M1128-CDK FDA UDI
- Primary DI / UDI-DI
- 07466532979321 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07466532979321 EUDAMED
- FDA Product Code
- PUI FDA UDI
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Rampart M1128 Drape Kit by Das Medical International, Srl — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07466532979321 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DAS Medical International, SRL
- EUDAMED SRN
- DO-MF-000034519
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 3239a71e-aa16-4c85-a693-5417c4b29df9 61 fields · synced Jun 18, 2026
- FDA UDI 89c2bb81-e1a3-45cd-bc10-4b1f3694c2dc 35 fields · synced May 30, 2026