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Spirotome
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SS-08-CEModel SS‐08‐10
by Bioncise NV
Identity
- Trade Name
- Spirotome EUDAMEDSpirotome Cervicore FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- Spirotome EUDAMEDThe Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 8G (5 mm) and length of 200 mm. FDA UDI
- Model / Reference
- SS‐08‐10 EUDAMEDSS-08-CE EUDAMEDSS08CE FDA UDI
- Description
- The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 8G (5 mm) and length of 200 mm. FDA UDI
Identifiers
- Catalog Number
- SS08CC FDA UDI
- Primary DI / UDI-DI
- 05407005001189 EUDAMEDFDA UDI
- Basic UDI-DI
- 5407005001035PU EUDAMED
- Direct Marketing DI
- 05407005001189 EUDAMED
- 510(k) Number
- K080095 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Spirotome by Bioncise NV — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5407005001035PU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bioncise NV
- EUDAMED SRN
- BE-MF-000000875
Sources (2)
- EUDAMED 9dc95955-8358-4617-8502-c80cbfd97065 61 fields · synced Jun 8, 2026
- FDA UDI 5a041605-94d4-4f58-82ba-8da782ea1863 35 fields · synced May 30, 2026