Identity
- Trade Name
- 8Tx24Rx Hand Wrist 7T EUDAMED
- Device Name
- MRI RF Coils EUDAMED
- Model / Reference
- Q7000205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814848020805 EUDAMED
- Basic UDI-DI
- 081484802RFCOILBV EUDAMED
- Direct Marketing DI
- 00814848020805 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
8Tx24Rx Hand Wrist 7T by Quality Electrodynamics Llc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED f45fab34-dc6f-449d-a151-6c03da814c02 61 fields · synced Jun 19, 2026