macu4 GmbH

FDA Device Registration & Listing · Konstanz Baden-Wurttemberg, DE · Registration 3042101018

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042101018
FEI Number
3042101018
Entity Name
macu4 GmbH
City/State/Country
Konstanz Baden-Wurttemberg, DE
Establishment Address
Buecklestr. 3, Konstanz Baden-Wurttemberg 78467, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
macu4 GmbH (Owner Number: 10094184)
Owner / Operator Contact Address
Buecklestr. 3, Konstanz, DE-BW 78467, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Lumo Spacer, STD-B Lumo Module Connector Lumo Spacer, STD-C Lumo Spacer, STD-E Lumo Spacer, STD-D Lumo Spacer, STD-A Explorer Ring EXP Explorer Swim Module SML without spacer Explorer Ball Module STD with spacer Explorer Pinch Module STD without spacer Explorer Ring STD Explorer Pinch Module spacer Explorer Ball Module SML with spacer Explorer Twin Module LRG without spacer Explorer Twin Module LRG with spacer Explorer Ball Module STD without spacer Explorer Ball Module SML without spacer Explorer Bike Module STD without spacer Explorer Swim Module STD without spacer Explorer Hold Module STD without spacer Explorer Twin Module STD with spacer Explorer Bike Module STD with spacer Explorer Hold Module spacer Explorer Twin Module STD without spacer Lynk Clic Lock Adapter Lynk Clic Lock Head 70°, STD Lumo Cuff, STD-SML-B Lynk Cover, SML Lynk Velcro Closure, Size: MED, Arm side: Left Lynk Clic Head 0° Lumo Cuff, STD-MED-E Lynk Push Module standard Lynk Velcro Closure, Size: MED, Arm side: Right Lynk Clic Head 360° Lynk Clic Lock Head 0°, ELLIPSE Lynk Velcro Closure, Size: XS, Arm side: Right Lumo Cuff, STD-MED-B Lumo Cuff, STD-MED-D Lumo Cuff, STD-SML-D Lynk Clic Lock Module Lynk Clic Module Lynk Cuff short-extra small Lynk Cover, MED Lynk Cuff short-small Lynk Velcro Closure, Size: LRG, Arm side: Left Lumo Cuff, STD-SML-C Lumo Cuff, STD-SML-A Lynk Clic Lock Head 360°, FLAT Lumo Cuff, STD-SML-E Lumo Clamp, STD Lynk Clic Lock Head 70°, ELLIPSE Lynk Cuff standard-medium Lynk Cover, LRG Lynk Hook Module standard Lynk Cuff short-large Lumo Shovel, STD Lynk Cuff standard-large Lynk Hold Lock Module Lynk Clic Lock Head 360°, STD Lynk Clic Lock Head 360°, ELLIPSE Lynk Velcro Closure, Size: SML, Arm side: Right Lynk Velcro Closure, Size: LRG, Arm side: Right Lynk Clic Lock Head 0°, STD Lynk Cuff short-medium Lynk Clic Adapter Lynk Clic Lock Head 0°, FLAT Lynk Velcro Closure, Size: SML, Arm side: Left Lumo Cuff, STD-MED-A Lynk Cuff standard-small Lynk Clic Lock Head 70°, FLAT Lynk Clic Head 70° Lumo Cuff, STD-MED-C Lumo Roll, STD Lynk Hold Module standard Lumo Hold, Lock Lynk Velcro Closure, Size: XS, Arm side: Left

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISS Prosthesis, Thigh Socket, External Component Physical Medicine Class 1 890.3420 2025-11-18
ISZ Unit, Wrist, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2025-11-18
ILT Adaptor, Recreational Physical Medicine Class 1 890.5050 2025-11-18

Official Correspondent

No official correspondent registered.

US Agent Details

Hannah Irwin Business: MCRA, LLC Email: hirwin@mcra.com Phone: (202) 5525820

Related Public Records

Same Entity

macu4 GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042101018. Last updated year: 2026. Please use registration number 3042101018 when referencing this establishment in official correspondence.
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