Identity
- Trade Name
- Senhance Arm Drape, Single Pack EUDAMEDTransEnterix FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Senhance Robotic Arm Drape, Single Pack EUDAMEDSenhance Manipulator Drape 1-PK X9007635 FDA UDI
- Model / Reference
- X9007635 EUDAMEDFDA UDI
- Description
- Senhance Manipulator Drape 1-PK X9007635 FDA UDI
Identifiers
- Catalog Number
- X9007635 FDA UDI
- Primary DI / UDI-DI
- 07466532979017 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07466532979017 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
- France 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
No
FDA UDI
Ethylene Oxide FDA UDI
Senhance Arm Drape, Single Pack 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-07466532979017 | 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 60835b08-e28c-4fb3-aae3-35274ac8a978 61 fields · synced Jul 11, 2026
- FDA UDI 17662596-b9af-4396-b0d9-7abe48ae9e96 35 fields · synced May 22, 2026