Identity
- Trade Name
- DXC-RML EUDAMEDDRGEM FDA UDI
- Generic Name
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
- Device Name
- X-ray collimator EUDAMED
- Model / Reference
- DXC-RML EUDAMEDFDA UDIDXC-RML, DXC-RMH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800011104016 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000111BLD0400TM EUDAMED
- FDA Product Code
- IZX FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1610 FDA UDI
- Market of Registration
- Poland 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Drgem by DRGEM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual-aperture-control diagnostic x-ray system collimator, non-motorized.
- iRay — Iray Imaging Technology (Haining) Limited · Class II
- Collimare — Collimare, LLC · Class II
- Collimare — Collimare, LLC · Class II
- Ralco srl — RALCO SRL · Class II
- Ralco srl — RALCO SRL · Class II
- iRay — Iray Imaging Technology (Haining) Limited · Class II
- R-20J — Shimadzu Corp. · Class II
- Ralco srl — RALCO SRL · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (2)
- FDA UDI 8cf0c6c8-4286-4d83-965a-713fccc9beff 32 fields · synced Jul 9, 2026
- EUDAMED 9153f71d-0aae-43ce-9196-9e29212a0bf8 61 fields · synced Jul 9, 2026