Identity
- Trade Name
- Dexter EUDAMEDDexter Sterile Interface FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Sterile Interface EUDAMEDDexter L6 Sterile Interface FDA UDI
- Model / Reference
- Dexter L6 EUDAMEDFDA UDI140 EUDAMED
- Description
- Dexter L6 Sterile Interface FDA UDI
Identifiers
- Catalog Number
- 140 FDA UDI
- Primary DI / UDI-DI
- 07640184840233 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018484AC-SU-SI001YV EUDAMED
- 510(k) Number
- DEN230084 FDA UDI
- FDA Product Code
- SDD FDA UDI
- EMDN Code
- K01020299 ROBOTIC SURGERY INSTRUMENT, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4965 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dexter by Distalmotion SA — 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 | 764018484AC-SU-SI001YV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Distalmotion SA
- EUDAMED SRN
- CH-MF-000037226
- Authorised Representative
- Distalmotion Deutschland GmbH DE-AR-000046740
Sources (2)
- EUDAMED 6363c3dc-cb60-4485-be53-b85cb029b38e 61 fields · synced Jun 8, 2026
- FDA UDI fe77901f-9fcd-4bf5-b2fa-00645962d402 36 fields · synced May 30, 2026