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K-Cem
EUDAMEDClass I (EU MDR)
Ref KCEMF20-AMSRef KCEMKYP-AMSRef KCEM-AMSRef KCEMBONOS-AMS
Identity
- Trade Name
- K-CEM EUDAMED
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDK-CEM EUDAMED
- Model / Reference
- KCEMF20-AMS EUDAMEDKCEMKYP-AMS EUDAMEDKCEM-AMS EUDAMEDKCEMBONOS-AMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860028053 EUDAMED08033860028985 EUDAMED08033860027858 EUDAMED08033860030711 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860027858 EUDAMEDB-08033860030711 EUDAMEDB-08033860028053 EUDAMEDB-08033860028985 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
K-Cem 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 (8)
- EUDAMED c0489ab3-3d65-4c7e-be4a-a8433cbf0690 61 fields · synced Aug 4, 2026
- EUDAMED 219c8adf-c579-4562-918f-94b599686a0a 61 fields · synced May 17, 2026
- EUDAMED 015a3c89-f80a-475d-9615-ad5ea8fc038d 61 fields · synced May 17, 2026
- EUDAMED 644c598b-b533-432d-b67f-35c3d26cc81b 61 fields · synced May 18, 2026
- EUDAMED 427a5769-8ba5-4280-bee1-bc4d860893f7 61 fields · synced Jun 18, 2026
- EUDAMED e5794c02-2cb3-4bc5-8166-68c0f982070e 61 fields · synced Jul 17, 2026
- EUDAMED ddaeae65-390d-4aab-8b41-2a25434c558c 61 fields · synced Jul 24, 2026
- EUDAMED 1bf0b1f4-c240-45b1-9b2c-fef3eb79b51f 61 fields · synced Aug 4, 2026