Identity
- Trade Name
- 16Ch AI Breast Coil 1.5T EUDAMED16 Ch AI BREAST COIL 1.5T FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Breast Coil EUDAMED
- Model / Reference
- 10185781(00863) EUDAMED10185781 02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260487680034 EUDAMEDFDA UDI
- Basic UDI-DI
- 426048768FAMBreast_IBJ EUDAMED
- Direct Marketing DI
- 04260487680034 EUDAMED
- 510(k) Number
- K083255 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
16Ch AI Breast Coil 1.5T by Rapid Biomedical Gmbh — 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 | 426048768FAMBreast_IBJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- RAPID Biomedical GmbH
- EUDAMED SRN
- DE-MF-000008285
Sources (2)
- EUDAMED 132ef349-138f-4b48-8437-a2f3d8866fa5 61 fields · synced Jul 13, 2026
- FDA UDI 813c1f03-bb08-4b7b-8b3a-5cfed72c0cf6 34 fields · synced May 30, 2026