Identity
- Trade Name
- ASPYNFINITY EUDAMED
- Device Name
- ACCESSORIES FOR BIOPSY OR EXPLANT EUDAMEDASPYNFINITY EUDAMED
- Model / Reference
- ASPY10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860004637 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT011SJ2 EUDAMEDB-08033860004637 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT011SJ2 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT011SJ2 | Class I | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 0d535bfe-af99-4222-8d52-dd76205a4563 61 fields · synced Sep 18, 2026
- EUDAMED edc551be-e6bf-465b-8312-ac92297085bb 61 fields · synced May 19, 2026