Monty 3D Plus

FDA UDIEUDAMED

Class I (US FDA UDI)

by REHAdapt Engineering GmbH & Co. KG

Identity

Trade Name: Monty 3D Plus FDA UDI
Generic Name: Portable active medical device mount FDA UDI
Device Name: M3D wheelchair mount ideal for eye-tracking devices. Tube lengths 300 x 500 x 400 mm (12 x 20 x 16"). UDS-DC and additional 500 mm (20") tube included. Max. load capacity: 6.0 kg (13.2 lbs). Frame clamp not included. FDA UDI
Model / Reference: 11.3312 FDA UDI
Description: M3D wheelchair mount ideal for eye-tracking devices. Tube lengths 300 x 500 x 400 mm (12 x 20 x 16"). UDS-DC and additional 500 mm (20") tube included. Max. load capacity: 6.0 kg (13.2 lbs). Frame clamp not included. FDA UDI

Identifiers

Primary DI / UDI-DI: B8961133120 FDA UDI
FDA Product Code: KNO FDA UDI
GMDN Term: Portable active medical device mount FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Portable active medical device mount

Monty 3D Plus by REHAdapt Engineering GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Portable active medical device mount.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: REHAdapt Engineering GmbH & Co. KG

Sources (2)

FDA UDI 6faf391e-2c17-46b5-a0d2-113283d8c07d 33 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 2, 2026