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Knochenzugangsnadel 11G/Lӓnge 15cm Bone access needle 11G/Length 15cm
EUDAMEDClass IIa (EU MDR)
Ref SM-BAN1115D
Identity
- Trade Name
- Knochenzugangsnadel 11G/Lӓnge 15cm Bone access needle 11G/Length 15cm EUDAMED
- Device Name
- CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMED
- Model / Reference
- SM-BAN1115D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860026950 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
Knochenzugangsnadel 11G/Lӓnge 15cm Bone access needle 11G/Length 15cm 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 4486e5ff-8cd0-4490-a959-5cfa6705bd53 61 fields · synced Jun 19, 2026