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Kyphokit Fast Access System
EUDAMEDClass IIa (EU MDR)
Ref KK11-002V-AMSRef KK11-001V-AMS
Identity
- Trade Name
- KYPHOKIT FAST ACCESS SYSTEM EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDKYPHOKIT FAST ACCESS SYSTEM EUDAMED
- Model / Reference
- KK11-002V-AMS EUDAMEDKK11-001V-AMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860027896 EUDAMED08033860027971 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860027896 EUDAMED
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa 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
Kyphokit Fast Access System by Biopsybell Srl — Class IIa — 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 | 8033860KYPFT05A9T | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A9T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 05d690fa-a722-4c79-b3a7-b7e550584e8a 61 fields · synced Jul 21, 2026
- EUDAMED dbc75e27-346b-4a53-8fb6-e76a2022c0ed 61 fields · synced May 17, 2026
- EUDAMED 6ae30756-be1d-4416-876b-7d8f436476f4 61 fields · synced Jul 18, 2026