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HighBridgeSupport RE

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 173530

by Macromedics B.v.

Identity

Trade Name
HighBridgeSupport RE EUDAMEDFDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Armsupport EUDAMED
High Bridge Support (RealEase) for lowerarms, carbon fiber FDA UDI
Model / Reference
173530 EUDAMED
HBSRE FDA UDI
Description
High Bridge Support (RealEase) for lowerarms, carbon fiber FDA UDI

Identifiers

Catalog Number
173530 FDA UDI
Primary DI / UDI-DI
08719425702759 EUDAMEDFDA UDI
Basic UDI-DI
872016816125300J3 EUDAMED
FDA Product Code
IYE FDA UDI
EMDN Code
Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Market of Registration
Netherlands EUDAMED
Northern Ireland 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

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

HighBridgeSupport RE 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 (3)

  • FDA UDI 7a7322cc-cd3b-47aa-a60e-03b3e2310b98 34 fields · synced Jul 19, 2026
  • EUDAMED 6b620bf1-0c96-4c3f-be80-1d8c8a138bba 61 fields · synced Jul 8, 2026
  • EUDAMED 93b73c90-7ee0-481c-bfa2-740905c844b0 61 fields · synced Jul 19, 2026