Identity
- Trade Name
- UniArm EUDAMEDFDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Device Name
- UniArm EUDAMEDThe UniARM is for use in holding medical devices such a endoscopes and retractors in surgery. FDA UDI
- Model / Reference
- UA EUDAMEDUA1 FDA UDI
- Description
- The UniARM is for use in holding medical devices such a endoscopes and retractors in surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589698450022 EUDAMEDFDA UDI
- Basic UDI-DI
- 458969845002PQ EUDAMED
- Direct Marketing DI
- 04589698450022 EUDAMED
- 510(k) Number
- K090792 FDA UDI
- FDA Product Code
- GWG FDA UDIGCJ FDA UDI
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
- GMDN Term
- Surgical instrument assist arm system, power-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1480 FDA UDI876.1500 FDA UDI
- Market of Registration
- Poland 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
UniArm by Mitaka Kohki Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090792 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 458969845002PQ | Class I | Active |
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Manufacturer
- Manufacturer
- Mitaka Kohki Co., Ltd.
- EUDAMED SRN
- JP-MF-000013028
- Authorised Representative
- Mitaka Europe GmbH DE-AR-000006361
Sources (3)
- EUDAMED 695144d9-7280-44a4-992a-76c29f27e424 61 fields · synced Jul 28, 2026
- FDA UDI 52f9e5e6-fcdf-41d4-9054-f199657116f5 34 fields · synced May 30, 2026
- FDA 510(k) K090792 1 fields · synced May 18, 2026