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Aditus Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref AKB20Ref AKB1310Ref AKB15Ref AKB1320
Identity
- Trade Name
- ADITUS BALLOON CATHETER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- AKB20 EUDAMEDAKB1310 EUDAMEDAKB15 EUDAMEDAKB1320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860033934 EUDAMED08033860034474 EUDAMED08033860033897 EUDAMED08033860034528 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMED
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Aditus Balloon Catheter by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A9T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (4)
- EUDAMED 69731f5d-e096-40bb-b528-9a921c2f938b 61 fields · synced Aug 1, 2026
- EUDAMED e99801cf-3aef-43ee-a568-b170c8c6057a 61 fields · synced May 11, 2026
- EUDAMED f49580e4-eb1b-4b55-b6ed-f5002f2d330c 61 fields · synced May 17, 2026
- EUDAMED eb7eba75-6c8c-448f-b7c0-ff20e636b17d 61 fields · synced May 18, 2026