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Senhance Articulating Drape
EUDAMEDFDA UDIClass I (EU MDR)
Ref X9007760 Senhance Articulating DrapeModel X9007760Ref X9007669 Senhance Articulating Drape Model X9007669
Identity
- Trade Name
- Senhance Articulating Drape EUDAMEDAsensus FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Senhance Articulating Drape EUDAMEDSenhance Articulating Drape (X9007760) FDA UDI
- Model / Reference
- X9007760 EUDAMEDX9007760 Senhance Articulating Drape EUDAMEDX9007669 EUDAMEDX9007669 Senhance Articulating Drape EUDAMEDX9007762 FDA UDI
- Description
- Senhance Articulating Drape (X9007760) FDA UDI
Identifiers
- Catalog Number
- X9007760 FDA UDI
- Primary DI / UDI-DI
- 07466532979239 EUDAMEDFDA UDI74665329790626 EUDAMED27466532979233 EUDAMED
- Basic UDI-DI
- B-07466532979239 EUDAMEDB-74665329790626 EUDAMED746742323X90077608Q EUDAMED
- Direct Marketing DI
- 27466532979233 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
- Bulgaria 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
Senhance Articulating 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-07466532979239 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07466532979239 | 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 (4)
- EUDAMED 9babacdd-5676-444e-83d7-95a648914c62 61 fields · synced Jul 19, 2026
- EUDAMED 0ec0269e-c72f-44ac-9235-55a55b87472f 61 fields · synced May 18, 2026
- FDA UDI 0849069d-20d8-495f-8b0f-54caf9924606 35 fields · synced May 29, 2026
- EUDAMED 0d4d6ee2-2c3e-47f1-9678-44bf6a873c3d 61 fields · synced Jun 18, 2026