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TheraSphere Administration Set (CEA)
EUDAMEDClass AIMDD (EU MDR)
Ref OTT-SPE-FP-226Model TheraSphere Administration Set (CEA) Box of 5
Identity
- Device Name
- TheraSphere Administration Set (CEA) EUDAMED
- Model / Reference
- TheraSphere Administration Set (CEA) Box of 5 EUDAMEDOTT-SPE-FP-226 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060116920260 EUDAMED
- Basic UDI-DI
- B-05060116920260 EUDAMED
- EMDN Code
- J0502 BRACHYTHERAPY ADMINISTRATION KITS EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
- Market of Registration
- Austria 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 (CEA) 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-05060116920260 | 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 195b47ea-ec9a-4193-bc47-d161463f632a 61 fields · synced Aug 2, 2026