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Rft

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 5869241-2Model 10-F31896

by Shenzhen RF Tech Co., Ltd.

Identity

Trade Name
RFT EUDAMEDFDA UDI
Generic Name
MRI system coil, radio-frequency FDA UDI
Device Name
8CH T/R KNEE COIL EUDAMED
The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician. FDA UDI
Model / Reference
10-F31896 EUDAMEDFDA UDI
5869241-2 EUDAMED
Description
The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician. FDA UDI

Identifiers

Catalog Number
5869241-2 FDA UDI
Primary DI / UDI-DI
06938146600102 EUDAMEDFDA UDI
Basic UDI-DI
69381466R08K10F318AF9 EUDAMED
510(k) Number
K223225 FDA UDI
FDA Product Code
MOS FDA UDI
EMDN Code
Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
MRI system coil, radio-frequency FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
Market of Registration
Belgium 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Width — 403 Millimeter FDA UDI
Height — 325 Millimeter FDA UDI
Depth — 358 Millimeter FDA UDI

Rft by Shenzhen RF Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen RF Tech Co., Ltd.
EUDAMED SRN
CN-MF-000010149
Authorised Representative
OSMUNDA Medical Technology Service GmbH DE-AR-000009285

Sources (2)

  • EUDAMED 87a5aac0-0cb3-4793-9fd1-f79292f15480 61 fields · synced May 30, 2026
  • FDA UDI 4b0b198a-54a3-4b32-9f3e-0cdedadad4d4 37 fields · synced May 30, 2026