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Themy
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TYC1610Ref TYC1420Ref TY1420Ref TY1615Ref TY1625Ref TYC1620Ref TYC1830Ref TYC1411Ref TY1815Ref TYC1612Ref TY1616Ref TYC1412
Identity
- Trade Name
- Themy EUDAMEDFDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- Themy EUDAMEDTHEMY AUTOMATIC NEEDLE 14G x 200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20mm FDA UDICS 5-THEMY AUTOMATIC NEEDLE 14Gx120mm NOTCH 20mm WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY FDA UDI5 CS- THEMY AUTOMATIC NEEDLE 16Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm FDA UDI
- Model / Reference
- TYC1610 EUDAMEDTYC1420 EUDAMEDTY1420 EUDAMEDFDA UDITY1615 EUDAMEDTY1625 EUDAMEDTYC1620 EUDAMEDTYC1830 EUDAMEDTYC1411 EUDAMEDTY1815 EUDAMEDTYC1612 EUDAMEDTYC1412 EUDAMEDFDA UDITY1616 EUDAMEDFDA UDI
- Description
- THEMY AUTOMATIC NEEDLE 14G x 200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20mm FDA UDICS 5-THEMY AUTOMATIC NEEDLE 14Gx120mm NOTCH 20mm WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY FDA UDI5 CS- THEMY AUTOMATIC NEEDLE 16Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm FDA UDI
Identifiers
- Catalog Number
- TY1420 FDA UDITYC1412 FDA UDITY1616 FDA UDI
- Primary DI / UDI-DI
- 08052440100231 EUDAMED08052440100224 EUDAMED08052440100064 EUDAMEDFDA UDI08058341210284 EUDAMED08058341215517 EUDAMED08052440100262 EUDAMED08052440100293 EUDAMED08052440103386 EUDAMED08052440109623 EUDAMED08052440100248 EUDAMED08052440100200 EUDAMEDFDA UDI08052440100088 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08052440100231 EUDAMEDB-08052440100224 EUDAMEDB-08052440100064 EUDAMEDB-08058341210284 EUDAMEDB-08058341215517 EUDAMEDB-08052440100262 EUDAMEDB-08052440100293 EUDAMEDB-08052440103386 EUDAMEDB-08052440109623 EUDAMEDB-08052440100248 EUDAMEDB-08052440100088 EUDAMEDB-08052440100200 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 — 14 Gauge FDA UDILength — 200 Millimeter FDA UDILength — 120 Millimeter FDA UDINeedle Gauge — 16 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-08052440100231 | 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 (15)
- EUDAMED ce939223-fec2-43eb-b0d3-3e2a17831fd3 61 fields · synced Oct 6, 2026
- EUDAMED d91dba7e-a97f-4697-9f24-d5acbe376f07 61 fields · synced May 17, 2026
- EUDAMED 5e8340a2-b3a4-4b39-82d7-baa681cd51d8 61 fields · synced May 17, 2026
- EUDAMED 1848ae2b-5527-4de7-b94d-ab3db85b9770 61 fields · synced May 17, 2026
- EUDAMED 73c072fd-81e2-4ac2-897f-7324658ac2eb 61 fields · synced May 17, 2026
- EUDAMED 6e492465-a81f-42f4-b422-e2b5b29f0930 61 fields · synced May 18, 2026
- EUDAMED bcf6e3f7-e808-4c2c-8fc7-d30e3a4603a2 61 fields · synced May 18, 2026
- EUDAMED 0889c179-7e36-4d1c-ad48-95cff80d118f 61 fields · synced May 18, 2026
- EUDAMED 2fafdfc9-bb19-4267-ad1f-0df78b87f5ab 61 fields · synced May 18, 2026
- EUDAMED dc6f8988-fb0d-40f7-9cfe-c313dce6d99e 61 fields · synced May 18, 2026
- FDA UDI a09a4ee4-55f9-487c-a0cc-677b47fbb741 37 fields · synced May 30, 2026
- FDA UDI f204cd4b-98aa-4493-b7f0-bd6a0e1090e6 37 fields · synced May 30, 2026
- FDA UDI 110b1024-6906-48b9-8d23-30ad71937726 37 fields · synced May 30, 2026
- EUDAMED 65ee45fa-9953-4f54-a7f2-783329564257 61 fields · synced Jul 21, 2026
- EUDAMED 285555d0-c5eb-4b31-8dd5-028d19581ee1 61 fields · synced Sep 30, 2026