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Syringe
EUDAMEDClass I (EU MDR)
Ref SI30BPB-YRef VAC110-BPBRef SI10PCBPBRef SI02.5L/L-A4D
Identity
- Trade Name
- SYRINGE EUDAMED
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDSYRINGE EUDAMED
- Model / Reference
- SI30BPB-Y EUDAMEDVAC110-BPB EUDAMEDSI10PCBPB EUDAMEDSI02.5L/L-A4D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860009793 EUDAMED08033860024086 EUDAMED08033860021061 EUDAMED08033860036287 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860021061 EUDAMEDB-08033860009793 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS 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
Syringe 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 | 8033860KYPFT05A1S3Z | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A1S3Z | Class I | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (6)
- EUDAMED 52ac1a42-4b72-4140-afaf-b947fac17650 61 fields · synced Jul 26, 2026
- EUDAMED e0aad2e8-aca8-4930-8f49-1080341c3df4 61 fields · synced May 16, 2026
- EUDAMED cfd5188f-a71f-498c-ab7b-75ee6a915bfb 61 fields · synced May 17, 2026
- EUDAMED 201f8a78-f113-4495-a34a-93c714d03bec 61 fields · synced May 18, 2026
- EUDAMED 8a22c3c0-dcbe-49d4-ad4e-d0f2e5762084 61 fields · synced Jul 11, 2026
- EUDAMED 2356d8a7-14c1-4d33-93ba-c9850686d9fb 61 fields · synced Jul 22, 2026