Eu Mdd
Eu Md Class 2b
On The Market
๐บ๐ธ United States
RS 3400 X-Ray Blood Irradiator
Devices (same UDI-DI)
1
Certificates
1
Countries
14
Notified Bodies
1
Basic Information
- Primary DI
- 00860000737005
- Basic UDI-DI Code
- B-00860000737005
- Reference
- RS 3400
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Rad Source Technologies Inc.
Additional Description
The RS 3400 is a medical device which uses X-ray irradiation to irradiate blood and blood products packaged in transfusion bags when irradiation for Graft Versus Host Disease (GVHD) is indicated. GVHD is a very rare but usually fatal complication following transfusion of lymphocyte-containing blood components, for which there is currently no treatment available.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11039012 | X-RAY TUBE ASSEMBLY |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 641606 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ท๐ด Romania
๐ธ๐ช Sweden
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