Identity
- Trade Name
- ADITUS FAST ACCESS SYSTEM EUDAMED
- Device Name
- ADITUS FAST ACCESS SYSTEM EUDAMEDKYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- AK-ACC1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860034016 EUDAMED
- Basic UDI-DI
- B-08033860034016 EUDAMED8033860KYPFT05A9T 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 Fast Access System by Biopsybell Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860034016 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860034016 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED d14de1c3-eb05-4bcb-b32d-83d326784948 61 fields · synced Jul 15, 2026
- EUDAMED b47f3314-8c15-429c-b0bd-e6415195855f 61 fields · synced May 17, 2026