Identity
- Trade Name
- CEMIX EUDAMED
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDCEMIX EUDAMED
- Model / Reference
- KVTMIX-LV EUDAMEDKVTMIX-LVSI2 EUDAMEDKVTMIX-LVPSI20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860009915 EUDAMED08033860013110 EUDAMED08033860026561 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860013110 EUDAMEDB-08033860026561 EUDAMEDB-08033860009915 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
Cemix 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 b5a08e74-c1d1-4ea7-ab93-4afb15fc4124 61 fields · synced Aug 3, 2026
- EUDAMED d5a8d715-4416-4f37-84c3-0f9a0e98c98c 61 fields · synced May 16, 2026
- EUDAMED 2a16a234-ba36-430a-aa4c-e96551b5c60a 61 fields · synced May 17, 2026
- EUDAMED bf2620e0-be4b-40a3-b132-9ce5d7a3834d 61 fields · synced Jul 9, 2026
- EUDAMED 9b0d5607-c5c7-419a-9adc-7c9f16b117bb 61 fields · synced Jul 9, 2026
- EUDAMED 471d8ff8-6b4e-4f02-900e-464d6f27e704 61 fields · synced Jul 14, 2026