Identity
- Trade Name
- BiomarC Restore Fiducial Marker EUDAMEDBIOMARC® RESTORE FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- BiomarC Restore Fiducial Marker EUDAMEDLOW DENSITY FIDUCIAL MARKER FDA UDI
- Model / Reference
- 040156 EUDAMEDFDA UDI
- Description
- LOW DENSITY FIDUCIAL MARKER FDA UDI
Identifiers
- Catalog Number
- 040156 FDA UDI
- Primary DI / UDI-DI
- 00850002461107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850002461107 EUDAMED
- FDA Product Code
- IYE 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 IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Width — 3 Centimeter FDA UDIHeight — 3 Centimeter FDA UDILength — 4 Centimeter FDA UDIWidth — 1 Millimeter FDA UDILength — 5 Millimeter FDA UDI
Category: Radiological image marker, implantable
Biomarc® Restore by Carbon Medical Technologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
Sources (2)
- FDA UDI d4ef6eee-3351-4b02-ba5b-634a7d95f713 36 fields · synced Jul 11, 2026
- EUDAMED 5bc41511-a2a7-4c54-9855-3c53797ba239 61 fields · synced Jul 11, 2026