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Senhance Arm Drape, W/ Verification Card
EUDAMEDFDA UDIClass I (EU MDR)
Ref X9007768 Senhance Arm Drape, W/ Verification CardModel X9007768
Identity
- Trade Name
- Senhance Arm Drape, W/ Verification Card EUDAMEDAsensus FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Senhance Arm Drape, W/ Verification Card EUDAMEDX9007768 Senhance Arm Drape, W/ Verification Card FDA UDI
- Model / Reference
- X9007768 EUDAMEDFDA UDIX9007768 Senhance Arm Drape, W/ Verification Card EUDAMED
- Description
- X9007768 Senhance Arm Drape, W/ Verification Card FDA UDI
Identifiers
- Catalog Number
- X9007768 FDA UDI
- Primary DI / UDI-DI
- 07466532979253 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07466532979253 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
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
Senhance Arm Drape, W/ Verification Card by Das Medical International, Srl — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-07466532979253 | 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 7576bcf7-0867-4fb8-89f4-5e0dcfd46671 61 fields · synced Jul 10, 2026
- FDA UDI 99358793-1017-43c7-86fd-41fa05be0bff 35 fields · synced May 30, 2026
- EUDAMED 7576bcf7-0867-4fb8-89f4-5e0dcfd46671-1 61 fields · synced Jun 9, 2026