Identity
- Trade Name
- MOUNT-1A EUDAMEDFDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- JOYSTICK EUDAMED
- Model / Reference
- 172066 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260463840667 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260463840038X EUDAMED
- Direct Marketing DI
- 04260463840667 EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- Z1202018099 REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Surgical camera holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Robotic surgical arm system
Mount-1a by Aktormed GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4260463840038X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-MF-000006136
Sources (2)
- EUDAMED 360cd59b-6581-44a8-8b13-2f243d49356c 61 fields · synced Jun 18, 2026
- FDA UDI c0d0a2f4-61b7-4ab0-b2f8-15e240e802d7 32 fields · synced May 30, 2026