Identity
- Trade Name
- ArmSure + Shield EUDAMEDArm Sure FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- ArmSure + Shield EUDAMEDSupport Furniture, Arm Embolization FDA UDI
- Model / Reference
- AM0610 EUDAMEDFDA UDI
- Description
- Support Furniture, Arm Embolization FDA UDI
Identifiers
- Catalog Number
- AM0610 FDA UDI
- Primary DI / UDI-DI
- 09421902825910 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190282591AM0610W8 EUDAMED
- Direct Marketing DI
- 09421902825910 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
ArmSure + Shield by Adept Medical Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942190282591AM0610W8 | 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
- Fineltec Oy FI-AR-000024641
Sources (2)
- EUDAMED 4a47c1f3-a10a-45de-910c-87fbf59b100f 61 fields · synced Jun 17, 2026
- FDA UDI d99f0af9-4a44-4055-9fcb-6d7f77ce7058 35 fields · synced May 29, 2026