IR Shield
Ref AM0500
IR Shield (AM0500) is a Class I device made by Adept Medical Ltd, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 942190282588AM0500Z4) and listed in FDA GUDID since 24 Nov 2017 (UDI-DI 09421902825880), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number942190282588AM0500Z4 09421902825880 | Date23 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number09421902825880 | Date24 Nov 2017 | StatusListed |
Official records
- EUDAMED public site 942190282588AM0500Z4
- AccessGUDID record 09421902825880
Across registries
- EUDAMED Basic UDI-DI 942190282588AM0500Z4 registered 23 Jun 2026 Active
- FDA GUDID UDI-DI 09421902825880 listed 24 Nov 2017 Listed
Timeline
- Listed FDA GUDID 09421902825880
- Registered EUDAMED 942190282588AM0500Z4
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Radiation shielding panel, portable/mobile
- Model / Ref / Catalog
- AM0500
- Primary DI / UDI-DI
- 09421902825880
- Basic UDI-DI
- 942190282588AM0500Z4
- FDA product code
- IWX
- EMDN code
- Z11039099 Various radiodiagnostic and interventional instruments – other
- GMDN term
- Radiation shielding panel, portable/mobile
- Device class
- Class I
- Regulation number
- 892.6500
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- NZ-MF-000003374
- Authorised representative
- Qualrep Services B.V. NL-AR-000000537
Similar devices in this category
Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER.
- Guardian™ Connect App CSS7201 by MEDTRONIC MINIMED, INC.
- FCR 1SHOT PHANTOM PLUS MDR E by FUJIFILM CORPORATION
- omniTRAX Patient Tracker Starter Kit 610-1227 by CIVCO MEDICAL INSTRUMENTS CO., INC.
- Omni TRAX Active Patient Tracker by CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
- LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub by Philips Medical Systems Nederland B.V.
- CLAROX plus(VX-100) by VSI Co., Ltd.
- ACIST Pro 016217 by ACIST Medical Systems, Inc.
- omniTRAX™ Active Patient Tracker Starter Kit 610-1299 by CIVCO MEDICAL INSTRUMENTS CO., INC.
- Planmed Verity 30010465 by Planmed Oy
- ScanX Duo Touch J1205 J1200 by Air Techniques, Inc.