Identity
- Trade Name
- Themy EUDAMEDFDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- Themy EUDAMED5 CS- THEMY AUTOMATIC NEEDLE 18Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm WITH COAXIAL FDA UDI
- Model / Reference
- TYC1816 EUDAMEDFDA UDI
- Description
- 5 CS- THEMY AUTOMATIC NEEDLE 18Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm WITH COAXIAL FDA UDI
Identifiers
- Catalog Number
- TYC1816 FDA UDI
- Primary DI / UDI-DI
- 08052440100286 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08052440100286 EUDAMED
- 510(k) Number
- K160316 FDA UDI
- FDA Product Code
- FCG FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- End-cut biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 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
No
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
- Needle Gauge — 18 Gauge FDA UDILength — 160 Millimeter FDA UDI
Themy by M.d.l. S.r.l. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-08052440100286 | 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 6c7b4cb4-3b1b-4999-a266-f2bea62860f7 61 fields · synced Oct 6, 2026
- FDA UDI b8e9a108-d7a1-4f63-9335-fa5a02a1529f 37 fields · synced May 30, 2026