Identity
- Trade Name
- CEMIX EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDCEMIX EUDAMEDVertebroplasty / Kyphoplasty cement mixing system FDA UDI
- Model / Reference
- KVTMIXN EUDAMEDCEMIX FDA UDI
- Description
- Vertebroplasty / Kyphoplasty cement mixing system FDA UDI
Identifiers
- Catalog Number
- KVTMIXN FDA UDI
- Primary DI / UDI-DI
- 08033860003449 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860003449 EUDAMED
- FDA Product Code
- JDZ FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4210 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cemix by Biopsybell Srl — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| 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 |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 47dea463-9b4f-448b-8bc9-f0a21ffc56e4 61 fields · synced Jul 15, 2026
- FDA UDI d503e3cf-75ae-48a3-91a2-2906fd63d683 35 fields · synced May 30, 2026
- EUDAMED 9c6bb5db-a736-447d-89f9-63419020fd8c 61 fields · synced Jun 18, 2026