Identity
- Trade Name
- Multi-Modality Fiducial Marker EUDAMEDSTRYKER FIDUCIAL MARKERS FDA UDI
- Generic Name
- Radiographic image marker, manual FDA UDI
- Device Name
- Multi-modality Fiducial Marker EUDAMED
- Model / Reference
- 6000-090-060 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212021664 EUDAMEDFDA UDI
- Basic UDI-DI
- 081521202MMmarkerLC EUDAMED
- Direct Marketing DI
- 00815212021664 EUDAMED
- 510(k) Number
- K014022 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11039085 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Radiographic image marker, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Multi-Modality Fiducial Marker by Izi Medical Products Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081521202MMmarkerLC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IZI Medical Products
- EUDAMED SRN
- US-MF-000029992
- Authorised Representative
- ILUMARK GmbH DE-AR-000011066
Sources (2)
- EUDAMED db88f526-00ee-47d1-9566-836121cfa91a 61 fields · synced Jun 18, 2026
- FDA UDI 9a5161cb-dc1d-4fc5-89c2-1b705e2b8201 33 fields · synced May 30, 2026