Identity
- Trade Name
- ASPYNFINITY EUDAMED
- Device Name
- ACCESSORIES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- ASPY25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860008338 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT011SJ2 EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Aspynfinity by Biopsybell Srl — Class I — 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 | 8033860BIOEFT011SJ2 | Class I | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (1)
- EUDAMED fdf9592f-3d89-44cb-b0db-f357268dcec3 61 fields · synced Jun 19, 2026