Identity
- Trade Name
- RS 3400 X-Ray Blood Irradiator EUDAMEDRS FDA UDI
- Generic Name
- In vitro ionizing-radiation blood irradiator FDA UDI
- Device Name
- RS 3400 X-Ray Blood Irradiator EUDAMEDBlood Irradiator FDA UDI
- Model / Reference
- RS 3400 EUDAMED3400 FDA UDI
- Description
- Blood Irradiator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000737005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860000737005 EUDAMED
- 510(k) Number
- K082921 FDA UDI
- FDA Product Code
- MOT FDA UDI
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
- GMDN Term
- In vitro ionizing-radiation blood irradiator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Sweden 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
RS 3400 X-Ray Blood Irradiator by Rad Source Technologies, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860000737005 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Rad Source Technologies Inc.
- EUDAMED SRN
- US-MF-000019415
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED cb9d12a0-99ad-4183-a7b8-f75a061ac919 61 fields · synced May 31, 2026
- FDA UDI 78c96013-beaa-4268-94e2-4782f1f445f2 35 fields · synced May 30, 2026