Identity
- Trade Name
- STARBoard Extension EUDAMEDFDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- STARBoard Extension Tray EUDAMEDExtension Accessory to Arm Support, for the support of Instruments during Interventional Radiology FDA UDI
- Model / Reference
- AM0190 EUDAMEDFDA UDI
- Description
- Extension Accessory to Arm Support, for the support of Instruments during Interventional Radiology FDA UDI
Identifiers
- Catalog Number
- AM0190 FDA UDI
- Primary DI / UDI-DI
- 09421902825897 EUDAMEDFDA UDI
- Basic UDI-DI
- 9421902825AM0190V3 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Instrument table FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
STARBoard Extension by Adept Medical Ltd — 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 | 9421902825AM0190V3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 91d56a8b-fb03-4db0-925d-791c1b4941de 61 fields · synced Jul 9, 2026
- FDA UDI 0dc48929-d945-4f58-8179-cb0a6a8d782a 34 fields · synced May 30, 2026