Identity
- Trade Name
- 1H/19F TxRx Loop EUDAMED
- Device Name
- MRI RF Coils EUDAMED
- Model / Reference
- Q7000105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814848020744 EUDAMED
- Basic UDI-DI
- 081484802RFCOILBV EUDAMED
- Direct Marketing DI
- 00814848020744 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
1H/19F TxRx Loop 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quality Electrodynamics, LLC
- EUDAMED SRN
- US-MF-000001417
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 913a3c2e-4a27-4fe7-9023-5d70e8710c63 61 fields · synced Jun 18, 2026