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Senhance Manipulator Arm Drape w/verification Card, 3 Pack
EUDAMEDFDA UDIClass I (EU MDR)
Ref X9007769 Senhance Manipulator Arm Drape w/verification Card, 3 PackModel X9007769
Identity
- Trade Name
- Senhance Manipulator Arm Drape w/verification Card, 3 Pack EUDAMEDAsensus FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Senhance Manipulator Arm Drape w/verification Card, 3 Pack EUDAMEDX9007769 Senhance Manipulator Arm Drape w/verification Card, 3 Pack FDA UDI
- Model / Reference
- X9007769 EUDAMEDFDA UDIX9007769 Senhance Manipulator Arm Drape w/verification Card, 3 Pack EUDAMED
- Description
- X9007769 Senhance Manipulator Arm Drape w/verification Card, 3 Pack FDA UDI
Identifiers
- Catalog Number
- X9007769 FDA UDI
- Primary DI / UDI-DI
- 07466532979260 EUDAMEDFDA UDI17466532979267 EUDAMED
- Basic UDI-DI
- B-07466532979260 EUDAMED746742323X90077699A EUDAMED
- Direct Marketing DI
- 17466532979267 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 Manipulator Arm Drape w/verification Card, 3 Pack by Das Medical International, Srl — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-07466532979260 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07466532979260 | 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 694352db-552f-499c-bbcd-6e3e455e7081 61 fields · synced Jul 15, 2026
- FDA UDI 83c5a0ce-d08e-4634-806f-63921324d730 35 fields · synced May 30, 2026
- EUDAMED 694352db-552f-499c-bbcd-6e3e455e7081-1 61 fields · synced Jun 10, 2026
- EUDAMED 741c7089-1282-4b75-932b-cc0b0d885147 61 fields · synced Jul 15, 2026