Identity
- Trade Name
- Master drape EUDAMEDMedical Micro Instrument FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- MASTER DRAPE EUDAMEDMASTER DRAPE (DRP-201-DO) FDA UDI
- Model / Reference
- DRP-201-DO EUDAMEDFDA UDIDRP-100-DO EUDAMED
- Description
- MASTER DRAPE (DRP-201-DO) FDA UDI
Identifiers
- Catalog Number
- DRP-201-DO FDA UDI
- Primary DI / UDI-DI
- 07467423230163 EUDAMEDFDA UDI27467423230167 EUDAMED
- Basic UDI-DI
- B-07467423230163 EUDAMED746742323DRP-201-DO6C EUDAMED
- Direct Marketing DI
- 27467423230167 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
- Belgium 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
Master drape by Das Medical International, Srl — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07467423230163 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07467423230163 | 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 ecf01f70-dbb1-437b-aa81-86e8554a1d17 61 fields · synced Jul 23, 2026
- FDA UDI a0329f71-28c4-414e-8414-f4df8f64cf7a 35 fields · synced May 30, 2026
- EUDAMED 65a3bba6-bed5-45fb-857b-e336161a63eb 61 fields · synced Jul 23, 2026