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User Interface Drape
EUDAMEDFDA UDIClass I (EU MDR)
Ref DR3500Ref DR3500 User interface Drape
Identity
- Trade Name
- User Interface Drape EUDAMEDProcept Biorobotics FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- User Interface Drape EUDAMEDUser interface Drape (DR3500) FDA UDI
- Model / Reference
- DR3500 EUDAMEDFDA UDIDR3500 User interface Drape EUDAMED
- Description
- User interface Drape (DR3500) FDA UDI
Identifiers
- Catalog Number
- DR3500 FDA UDI
- Primary DI / UDI-DI
- 27467423230341 EUDAMED07467423230347 EUDAMEDFDA UDI
- Basic UDI-DI
- 746742323DR35006E EUDAMEDB-07467423230347 EUDAMED
- Direct Marketing DI
- 27467423230341 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
- Germany EUDAMEDBulgaria 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
No
EUDAMEDFDA UDI
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
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
User Interface Drape by Das Medical International, Srl — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 746742323DR35006E | Class I | Active |
| EUDAMED | European Union | CE/MDR | 746742323DR35006E | 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 (3)
- EUDAMED 3501b89f-c634-48e9-b011-4743c1d0d76b 61 fields · synced Jul 9, 2026
- EUDAMED 95ef3654-66f3-467e-9f31-a51345d74719 61 fields · synced May 19, 2026
- FDA UDI f92987e0-f1ed-4ce2-bfb0-99b40e39a212 35 fields · synced May 25, 2026