← Back to catalogue

Na-140-Flex Coil

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 459801706231

by RAPID Biomedical GmbH

Identity

Trade Name
Na-140-Flex Coil EUDAMEDFDA UDI
Generic Name
MRI system coil, radio-frequency FDA UDI
Device Name
Surface Coil EUDAMED
Na-140-Flex Coil FDA UDI
Model / Reference
459801706231 EUDAMED
01790 FDA UDI
45980170623x FDA UDI
Description
Na-140-Flex Coil FDA UDI

Identifiers

Primary DI / UDI-DI
04260487680539 EUDAMEDFDA UDI
04260487680072 FDA UDI
Basic UDI-DI
426048768FAMSurf_IIaKM EUDAMED
Direct Marketing DI
04260487680539 EUDAMED
510(k) Number
K163661 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 EUDAMED
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI
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

No

FDA UDI

Na-140-Flex Coil by RAPID Biomedical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
RAPID Biomedical GmbH

Sources (3)

  • FDA UDI af3b85d2-38df-42af-9436-b563a606300c 36 fields · synced Jul 11, 2026
  • FDA UDI f39c6c39-0c65-459d-93d3-3b2f99faec07 35 fields · synced May 30, 2026
  • EUDAMED 2d6579fd-4426-4823-ba39-4c7b32e0b83f 61 fields · synced Jul 11, 2026