Identity
- Trade Name
- Overhead Arm Support MR Safe EUDAMEDAdept Medical Overhead Arm Support MR Safe FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- Overhead Arm Support MR Safe EUDAMEDTo Support the patient's arms overhead with controller shoulder flexion for imaging. Intended for bores 70cm and upwards FDA UDI
- Model / Reference
- AM4000B EUDAMEDFDA UDI
- Description
- To Support the patient's arms overhead with controller shoulder flexion for imaging. Intended for bores 70cm and upwards FDA UDI
Identifiers
- Catalog Number
- AM4000B FDA UDI
- Primary DI / UDI-DI
- 09421905187725 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190518740AM4000W5 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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
Yes
FDA UDI
Liquid Chemical FDA UDI
MR Safe FDA UDI
Overhead Arm Support MR Safe 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 | 942190518740AM4000W5 | 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 8e02dfe7-d58d-463f-9cae-aca31e3efae6 61 fields · synced Jun 17, 2026
- FDA UDI 380d8f50-0433-4513-a7d7-a72ca9c17b7e 34 fields · synced May 30, 2026