Identity
- Trade Name
- Contour Knee EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- MRI RF Coils EUDAMED
- Model / Reference
- Q7000187 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814848020751 EUDAMEDFDA UDI
- Basic UDI-DI
- 081484802RFCOILBV EUDAMED
- Direct Marketing DI
- 00814848020751 EUDAMED
- 510(k) Number
- K223429 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 IIa 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
Yes
FDA UDI
Contour Knee by Quality Electrodynamics Llc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223429 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081484802RFCOILBV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Quality Electrodynamics, LLC
- EUDAMED SRN
- US-MF-000001417
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 5fb3c787-3755-4e81-bdee-4432a800722e 61 fields · synced Jul 15, 2026
- FDA UDI d7a57ed7-aad0-4eeb-a1fc-a6359bf15f3a 33 fields · synced May 30, 2026
- FDA 510(k) K223429 1 fields · synced May 18, 2026