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Rti-K
EUDAMEDClass IIa (EU MDR)
Ref RTI-KDC1Ref RTI-KG11TRef RTI-K112Ref RTI-KG11BRef RTI-KB20J
Identity
- Trade Name
- RTI-K EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRTI-K EUDAMED
- Model / Reference
- RTI-KDC1 EUDAMEDRTI-KG11T EUDAMEDRTI-K112 EUDAMEDRTI-KG11B EUDAMEDRTI-KB20J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860032517 EUDAMED08033860032487 EUDAMED08033860031794 EUDAMED08033860032500 EUDAMED08033860031763 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860032517 EUDAMEDB-08033860031794 EUDAMEDB-08033860031763 EUDAMEDB-08033860032500 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMEDK010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Rti-K 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 (9)
- EUDAMED 032ae81e-49b2-4e05-9635-dfe152f2ef83 61 fields · synced Jul 23, 2026
- EUDAMED 03fc6e03-b2eb-4568-900c-37634a500d3a 61 fields · synced May 17, 2026
- EUDAMED af970d1d-a9b8-4b0b-b142-0809073a1c36 61 fields · synced May 18, 2026
- EUDAMED 6876c9d4-edeb-4c9e-a110-8d39dd9aa448 61 fields · synced May 18, 2026
- EUDAMED 1f937b9c-6882-4716-bbcc-3d20d776f167 61 fields · synced May 19, 2026
- EUDAMED a77ff346-bda7-4e7a-a82e-2bcbb4dcc372 61 fields · synced Jul 11, 2026
- EUDAMED b8ebc965-0fb3-4025-882c-8ca4e7b1d691 61 fields · synced Jul 12, 2026
- EUDAMED e403850c-75f9-4cfd-ad77-fc92387f42f6 61 fields · synced Jul 18, 2026
- EUDAMED 4e12988f-0c20-4edf-b459-ab1522906bb9 61 fields · synced Jul 23, 2026