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TheraSphere Administration Set (B Braun)
EUDAMEDClass AIMDD (EU MDR)
Ref OTT-SPE-FP-001Model TheraSphere Administration Set (B Braun); Box of 5
Identity
- Trade Name
- TheraSphere Administration Set (B Braun) EUDAMED
- Device Name
- TheraSphere Administration Set (B Braun) EUDAMED
- Model / Reference
- TheraSphere Administration Set (B Braun); Box of 5 EUDAMEDOTT-SPE-FP-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060116920642 EUDAMED
- Basic UDI-DI
- B-05060116920642 EUDAMED
- EMDN Code
- J0502 BRACHYTHERAPY ADMINISTRATION KITS EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TheraSphere Administration Set (B Braun) by Biocompatibles UK Limited — Class AIMDD — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060116920642 | Class AIMDD | Active |
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Manufacturer
- Manufacturer
- Biocompatibles UK Limited
- EUDAMED SRN
- UK-MF-000052971
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (1)
- EUDAMED e285f8bb-3a85-466c-bed2-f36808242c66 61 fields · synced Jul 24, 2026