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Contour Hand Wrist
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Q7000232510(k) K233652
Identity
- Trade Name
- Contour Hand Wrist EUDAMED
- Device Name
- MRI RF Coils EUDAMED
- Model / Reference
- Q7000232 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814848020836 EUDAMED
- Basic UDI-DI
- 081484802RFCOILBV EUDAMED
- Direct Marketing DI
- 00814848020836 EUDAMED
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Contour Hand Wrist by Quality Electrodynamics Llc — Class IIa — FDA_510K, MDR — listed in EUDAMED, 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 | K233652 | 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
- FDA Applicant
- Quality Electrodynamics
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED da055b99-ed11-4005-9dba-b0df65994c97 85 fields · synced Jun 18, 2026
- FDA 510(k) K233652 1 fields · synced May 18, 2026