Identity
- Trade Name
- IR Shield EUDAMEDFDA UDI
- Generic Name
- Radiation shielding panel, portable/mobile FDA UDI
- Device Name
- IR Shield EUDAMEDScatter Radiation Protection Shield FDA UDI
- Model / Reference
- AM0500 EUDAMEDFDA UDI
- Description
- Scatter Radiation Protection Shield FDA UDI
Identifiers
- Catalog Number
- AM0500 FDA UDI
- Primary DI / UDI-DI
- 09421902825880 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190282588AM0500Z4 EUDAMED
- FDA Product Code
- IWX 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
- 892.6500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- 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
IR 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 | 942190282588AM0500Z4 | 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 3148707e-259a-4cce-a97f-926848ab8c21 61 fields · synced Jun 19, 2026
- FDA UDI 4267ad8a-796b-482b-a085-36715dbd0ecd 34 fields · synced May 30, 2026