Identity
- Trade Name
- RepoMark EUDAMEDFDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- RepoMark EUDAMEDREPOSITIONABLE NEEDLE, HOMER TYPE 20G X 100mm FOR MAMMARY NODULES LOCALIZATION, SINGLE HOOK, FDA UDI
- Model / Reference
- PR2010 EUDAMEDFDA UDI
- Description
- REPOSITIONABLE NEEDLE, HOMER TYPE 20G X 100mm FOR MAMMARY NODULES LOCALIZATION, SINGLE HOOK, FDA UDI
Identifiers
- Catalog Number
- PR2010 FDA UDI
- Primary DI / UDI-DI
- 08052440107858 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08052440107858 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 — 70 Millimeter FDA UDINeedle Gauge — 20 Gauge FDA UDI
RepoMark 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-08052440107858 | 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 9ccf966f-a915-4afb-b3a2-eaaf52637255 61 fields · synced Oct 8, 2026
- FDA UDI 8aebd01a-3155-4a74-9ce2-2ac24472c563 36 fields · synced May 30, 2026