Identity
- Trade Name
- RepoMark EUDAMEDFDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- RepoMark EUDAMED5 CS - REPOSITIONABLE NEEDLE, HOMER TYPE 20G X 50mm FOR MAMMARY NODULES LOCALIZATION, SINGLE HOOK FDA UDI
- Model / Reference
- PR2005 EUDAMEDFDA UDIPR2003 EUDAMED
- Description
- 5 CS - REPOSITIONABLE NEEDLE, HOMER TYPE 20G X 50mm FOR MAMMARY NODULES LOCALIZATION, SINGLE HOOK FDA UDI
Identifiers
- Catalog Number
- PR2005 FDA UDI
- Primary DI / UDI-DI
- 08032986359867 EUDAMEDFDA UDI08032986359850 EUDAMED
- Basic UDI-DI
- B-08032986359867 EUDAMEDB-08032986359850 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 — 50 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-08032986359867 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- M.D.L. S.r.l.
- EUDAMED SRN
- IT-MF-000011599
Sources (3)
- EUDAMED be1943ce-bcb0-4625-9f08-7ac0fdefff90 61 fields · synced Oct 6, 2026
- EUDAMED 052446f5-527d-4691-8195-1a50c7391795 61 fields · synced May 17, 2026
- FDA UDI 900b6acc-fa82-4153-a213-d2da217d90eb 36 fields · synced May 30, 2026