Signa Hd 1.5t Phased Array Shoulder Coil
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- SIGNA HD 1.5T PHASED ARRAY SHOULDER COIL EUDAMEDNA FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 1.5T and 3.0T HD Shoulder Arrays EUDAMED
- Model / Reference
- 1.5T and 3.0T HD Shoulder Arrays EUDAMED2415364 EUDAMEDSIGNA HD 1.5T PHASED ARRAY SHOULDER COIL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682114387 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00362HH EUDAMED
- 510(k) Number
- K010946 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: MRI system coil, radio-frequency
Signa Hd 1.5t Phased Array Shoulder Coil by GE Healthcare Coils — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00362HH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Coils
- EUDAMED SRN
- US-MF-000001664
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED dc2da0e6-594a-41de-90ed-608570d1abd1 61 fields · synced Jul 21, 2026
- FDA UDI 24cff6ed-a55d-4994-8a03-40bffe9014c1 33 fields · synced May 30, 2026