Identity
- Trade Name
- REVOLUTION J-STYLE NEEDLE EUDAMED
- Device Name
- CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMED
- Model / Reference
- 116209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860018627 EUDAMED
- Basic UDI-DI
- 8033860SFFT01CU2 EUDAMED
- EMDN Code
- A018003 NEEDLE INTRODUCERS 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
Revolution J-Style Needle by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8033860SFFT01CU2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (1)
- EUDAMED 10d5f472-ed63-4bdd-9bcd-13bbe8688612 61 fields · synced Jul 10, 2026