Identity
- Trade Name
- 3D-RD EUDAMED3D-RD-S FDA UDI
- Generic Name
- Nuclear medicine system workstation FDA UDI
- Device Name
- 3D-RD-S EUDAMEDThe device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions. FDA UDI
- Model / Reference
- 3DRD-001 EUDAMEDFDA UDI
- Description
- The device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009926905 EUDAMEDFDA UDI
- Basic UDI-DI
- 086000992693DRDSN4 EUDAMED
- Direct Marketing DI
- 00860009926905 EUDAMED
- 510(k) Number
- K212587 FDA UDI
- FDA Product Code
- IYX FDA UDI
- EMDN Code
- Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Nuclear medicine system workstation FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1100 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3d-Rd by Radiopharmaceutical Imaging and Dosimetry, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 086000992693DRDSN4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Radiopharmaceutical Imaging and Dosimetry, LLC
- EUDAMED SRN
- US-MF-000037507
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 920c208d-8055-4bb9-b084-3717004ee150 61 fields · synced Jul 22, 2026
- FDA UDI 6de08a79-a41e-42e5-8d9e-db5ae09f7e8a 35 fields · synced May 29, 2026