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FlexBoard™ BTM-EX

FDA UDIEUDAMED

Class II (US FDA UDI)

by Macromedics B.v.

Identity

Trade Name
FlexBoard™ BTM-EX FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
BreastBoard EX module FDA UDI
Model / Reference
FBEXM FDA UDI
Description
BreastBoard EX module FDA UDI

Identifiers

Catalog Number
172120 FDA UDI
Primary DI / UDI-DI
08720168160508 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Indexed-immobilization patient positioning system

FlexBoard™ BTM-EX by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Macromedics B.v.

Sources (2)

  • FDA UDI 573b7e49-68d0-46a9-b06d-60a495b0366a 34 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026