Identity
- Trade Name
- DEXTER ENDOSCOPE ARM EUDAMEDFDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- SOLOASSIST II EUDAMEDcustomized SOLOASSIST II for Dexter, incl. Power supply and supply cable FDA UDI
- Model / Reference
- 212499 EUDAMEDFDA UDI
- Description
- customized SOLOASSIST II for Dexter, incl. Power supply and supply cable FDA UDI
Identifiers
- Catalog Number
- 212499 FDA UDI
- Primary DI / UDI-DI
- 04260463844993 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260463840018T EUDAMED
- 510(k) Number
- K233312 FDA UDI
- FDA Product Code
- QZB FDA UDI
- EMDN Code
- Z1202018001 ROBOTIC ARMS FOR VIDEOENDOSCOPY 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
- Netherlands 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
Dexter Endoscope Arm by Aktormed GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 4260463840018T | 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 fda22403-4adf-410a-8174-35ecdb9f73a0 61 fields · synced May 30, 2026
- FDA UDI 952118f8-5e90-4507-885d-f3678cae0199 36 fields · synced May 30, 2026