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Olympus EndoEye 3D 10 mm Endoscope Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref X9007680Model Senhance Adapters
Identity
- Trade Name
- Olympus EndoEye 3D 10 mm Endoscope Adapter EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Adapter, Allis Grasper Ø 5 mm x 240 mm EUDAMEDOlympus ENDOEYE 3D 10 mm Endoscope Adapter FDA UDI
- Model / Reference
- Senhance Adapters EUDAMEDX9007680 EUDAMEDFDA UDI
- Description
- Olympus ENDOEYE 3D 10 mm Endoscope Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815440021924 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD006UP EUDAMED
- Direct Marketing DI
- 00815440021924 EUDAMED
- 510(k) Number
- K171120 FDA UDI
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- Z1202018099 REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Olympus EndoEye 3D 10 mm Endoscope Adapter by Asensus Surgical Italia S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081544002TD006UP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (2)
- EUDAMED 39911c7d-de8b-477a-98ab-2de9d5ecdf8b 61 fields · synced Jul 14, 2026
- FDA UDI b22e5f38-6aad-4a07-9fc1-a6d7005b91a3 34 fields · synced May 30, 2026