Identity
- Trade Name
- SHAKER EUDAMED
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDSHAKER EUDAMED
- Model / Reference
- KPASH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860040451 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860040451 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
Shaker 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 (2)
- EUDAMED d12f60f1-6d3d-4578-8c02-f619be8a23a8 61 fields · synced Sep 17, 2026
- EUDAMED 88243154-38f0-407c-9103-dcf0738c0822 61 fields · synced Sep 17, 2026