Identity
- Trade Name
- ArmSure Shield EUDAMEDArm Sure Shield FDA UDI
- Generic Name
- Radiation shielding panel, portable/mobile FDA UDI
- Device Name
- ArmSure Shield EUDAMEDX-Ray Shield to ArmSure FDA UDI
- Model / Reference
- AM0630 EUDAMEDFDA UDI
- Description
- X-Ray Shield to ArmSure FDA UDI
Identifiers
- Catalog Number
- AM0630 FDA UDI
- Primary DI / UDI-DI
- 09421902825934 EUDAMEDFDA UDI
- Basic UDI-DI
- 9421902825AM0630VA EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiation shielding panel, portable/mobile 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
No
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 | 9421902825AM0630VA | 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 a0d35576-8219-4226-88d1-62d5a39e3186 61 fields · synced Jul 11, 2026
- FDA UDI cc596598-6507-429e-b01e-1c2cc1b9a13b 35 fields · synced May 30, 2026