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Spirotome SS‐16-FL
EUDAMEDClass IIa (EU MDR)
Ref 05407005001301Model SS‐08‐10
by Bioncise NV
Identity
- Trade Name
- Spirotome SS‐16-FL EUDAMED
- Device Name
- Spirotome EUDAMED
- Model / Reference
- SS‐08‐10 EUDAMED05407005001301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05407005001301 EUDAMED
- Basic UDI-DI
- 5407005001035PU EUDAMED
- Direct Marketing DI
- 05407005001301 EUDAMED
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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
Spirotome SS‐16-FL by Bioncise NV — 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 | 5407005001035PU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioncise NV
- EUDAMED SRN
- BE-MF-000000875
Sources (1)
- EUDAMED ad6335a0-0402-4c8f-a2de-d54f7b973848 61 fields · synced Jul 10, 2026