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UniRay
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref UFGS3502Model Latex Free PRIMERef UFD42016Model RADBLOCKRef UFGS3505Ref UFD42004Ref UFD42002Ref UFGL3502Model Latex PRIMERef UFGL3506Ref UFGL2005Model Latex SHEERRef UFGL2002Ref UFGS3506Ref UFGL3505Ref UFGL3503
Identity
- Trade Name
- UniRay EUDAMEDFDA UDI
- Generic Name
- Radiation shielding apron FDA UDIPatient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Sterile Surgical (non-invasive) Radiation Protection Gloves EUDAMEDSterile Radiation Shields and Drapes EUDAMEDCoat Apron with back protection - 0.35mm LiteLead - Large FDA UDIRadBlock Multipurpose use without Fenestration (Medium) FDA UDIRadBlock EP (Medium) FDA UDI
- Model / Reference
- Latex Free PRIME EUDAMEDUFGS3502 EUDAMEDRADBLOCK EUDAMEDUFD42016 EUDAMEDUFGS3505 EUDAMEDUFD42004 EUDAMEDUFD42002 EUDAMEDLatex PRIME EUDAMEDUFGL3502 EUDAMEDUFGL3506 EUDAMEDLatex SHEER EUDAMEDUFGL2005 EUDAMEDUFGL2002 EUDAMEDUFGS3506 EUDAMEDUFGL3505 EUDAMEDUFGL3503 EUDAMEDUF113622 FDA UDIUFD42B04 FDA UDIUFD42B02 FDA UDI
- Description
- Coat Apron with back protection - 0.35mm LiteLead - Large FDA UDIRadBlock Multipurpose use without Fenestration (Medium) FDA UDIRadBlock EP (Medium) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904333240404 EUDAMEDFDA UDI08904333234021 EUDAMEDFDA UDI08904333200019 EUDAMED08904333234144 EUDAMED08904333200040 EUDAMED08904333200217 EUDAMED08904333200255 EUDAMED08904333200316 EUDAMED08904333200286 EUDAMED08904333200057 EUDAMED08904333200248 EUDAMED08904333200224 EUDAMED08904333219004 FDA UDI
- Basic UDI-DI
- 89043332UFGS350QV EUDAMED89043332RADBLOCKX6 EUDAMED89043332UFGL350PC EUDAMED89043332UFGL200NQ EUDAMED
- FDA Product Code
- IWO FDA UDIKPY FDA UDI
- EMDN Code
- T0199 GLOVES - OTHER EUDAMEDT0210 NON-SURGICAL DRAPES EUDAMED
- GMDN Term
- Radiation shielding apron FDA UDIPatient radiation shielding pad/drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDIEUDAMED
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
Yes
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 UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation shielding apron
UniRay by Uniray Medical Llp — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Uniray Medical Llp
Sources (15)
- FDA UDI 46fea865-6645-42af-818d-46bbe63bde00 33 fields · synced Oct 6, 2026
- FDA UDI 540a01ef-cecb-4d2e-9159-13b080fcd338 33 fields · synced May 25, 2026
- FDA UDI 6a382efd-ce8d-4abe-8ac5-798f8466c183 33 fields · synced May 30, 2026
- EUDAMED a20564cf-7a46-447c-b69f-a2125c740be6 61 fields · synced Jul 8, 2026
- EUDAMED 3d5874cd-3692-499a-a5c8-6c2c614741c2 61 fields · synced Jul 9, 2026
- EUDAMED 7f38be91-9373-46f3-bf72-1c82660dcf5d 61 fields · synced Jul 9, 2026
- EUDAMED ed64182c-2e0e-4f63-b6a4-aaf9cfbf5e4d 61 fields · synced Jul 10, 2026
- EUDAMED 5c29aba5-472c-4ead-a227-454fda1ef4af 61 fields · synced Jul 11, 2026
- EUDAMED 1d897d7d-8f23-4268-88db-f70bdd704f5e 61 fields · synced Jul 11, 2026
- EUDAMED 84b70394-08d1-4cbb-b650-b40cec2b74bb 61 fields · synced Jul 13, 2026
- EUDAMED 0f3cce99-fc81-412a-aee7-07c8cae2d416 61 fields · synced Jul 21, 2026
- EUDAMED b87708d2-ea4b-416c-a2c8-9986f4319fde 61 fields · synced Jul 22, 2026
- EUDAMED 9cc920cd-43e2-45e7-ae52-3babb821b64f 61 fields · synced Jul 22, 2026
- EUDAMED 98058eef-2fac-4c90-856e-afdf672ef3a6 61 fields · synced Jul 27, 2026
- EUDAMED 6319e347-55ca-496e-a1d2-f956e331a219 61 fields · synced Aug 4, 2026