Identity
- Trade Name
- CytoCut EUDAMEDFDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- CytoCut EUDAMED10 CS - DISPOSABLE CHIBA NEEDLE 18G x 250 mm FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY FDA UDI
- Model / Reference
- PB1825 EUDAMEDFDA UDI
- Description
- 10 CS - DISPOSABLE CHIBA NEEDLE 18G x 250 mm FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY FDA UDI
Identifiers
- Catalog Number
- PB1825 FDA UDI
- Primary DI / UDI-DI
- 08032986351953 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08032986351953 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 250 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
Category: Diskectomy system, percutaneous, automatic
CytoCut by M.d.l. S.r.l. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- INTRODUTTORE — BIOPSYBELL SRL · Class IIa
- CHIBELL CON SIRINGA — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- 0ME2320 — Biomedical S.r.l. · Class IIa
- 0ME1810 — Biomedical S.r.l. · Class IIa
- DISKIT — BIOPSYBELL SRL · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08032986351953 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- M.D.L. S.r.l.
- EUDAMED SRN
- IT-MF-000011599
Sources (2)
- EUDAMED 4e50c85c-fc76-48e3-a8d8-fc8d9bdc69a9 61 fields · synced Jul 28, 2026
- FDA UDI e6359121-8e50-483f-9dd0-88491e577b81 36 fields · synced May 30, 2026