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MarkX
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PNX1805Ref PNX1812Ref PNX1810Ref PNX2005Ref PNX2010
Identity
- Trade Name
- MarkX EUDAMEDMark FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- MarkX EUDAMED10 CS - NOT REPOSITIONABLE NEEDLE 20G X 100mm FOR MAMMARY NODULES LOCALIZATION WITH DOUBLE HOOK FDA UDI
- Model / Reference
- PNX1805 EUDAMEDPNX1812 EUDAMEDPNX1810 EUDAMEDPNX2005 EUDAMEDPNX2010 EUDAMEDFDA UDI
- Description
- 10 CS - NOT REPOSITIONABLE NEEDLE 20G X 100mm FOR MAMMARY NODULES LOCALIZATION WITH DOUBLE HOOK FDA UDI
Identifiers
- Catalog Number
- PNX2010 FDA UDI
- Primary DI / UDI-DI
- 08032986359751 EUDAMED08032986356026 EUDAMED08052440107384 EUDAMED08032986359775 EUDAMED08052440107445 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08032986359751 EUDAMEDB-08032986356026 EUDAMEDB-08052440107384 EUDAMEDB-08032986359775 EUDAMEDB-08052440107445 EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Radiological image marker, implantable 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 — 100 Millimeter FDA UDINeedle Gauge — 20 Gauge FDA UDI
MarkX 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-08032986359751 | 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 (6)
- EUDAMED 2a8946f6-4af4-4152-93ae-383302e784f0 61 fields · synced Oct 6, 2026
- EUDAMED b89ed6bf-3762-469d-93ad-f63a10294031 61 fields · synced May 18, 2026
- EUDAMED 7ed467f6-4331-4657-83b2-187caebda07b 61 fields · synced May 18, 2026
- EUDAMED abea8566-e010-44ed-834d-72981d6bada7 61 fields · synced May 18, 2026
- EUDAMED 0463db45-f87e-41a2-9aa6-f1f461624e41 61 fields · synced May 19, 2026
- FDA UDI be7743f8-b302-439e-9e53-bbc5d998bd88 36 fields · synced May 30, 2026