Identity
- Trade Name
- SYRINGE EUDAMEDVERTESTABLE SYRINGE WITH LUER-LOCK CONNECTION 2.5 ML (1 UNIT/POUCH) EUDAMED
- Device Name
- SYRINGE EUDAMEDACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMED
- Model / Reference
- 458070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860040628 EUDAMED
- Basic UDI-DI
- B-08033860040628 EUDAMED8033860KYPFT05A1S3Z EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMEDP099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Syringe 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-08033860040628 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860040628 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED b93ec923-5af3-4e0f-82c6-484890af4663 61 fields · synced Jul 24, 2026
- EUDAMED 19df6fc6-79ff-4eba-8ddd-ebece4607040 61 fields · synced May 19, 2026