Identity
- Trade Name
- Monty 3D QuickShift Sturdy FDA UDI
- Generic Name
- Portable active medical device mount FDA UDI
- Device Name
- M3D wheelchair mount with a RotLok base for extra stability (e.g. mounting on the left side). Tube lengths: 200 x 500 x 400 mm (8 x 20 x 16"). Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included. FDA UDI
- Model / Reference
- 11.3311 FDA UDI
- Description
- M3D wheelchair mount with a RotLok base for extra stability (e.g. mounting on the left side). Tube lengths: 200 x 500 x 400 mm (8 x 20 x 16"). Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B8961133110 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Portable active medical device mount
Monty 3D QuickShift Sturdy by REHAdapt Engineering GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 ca297798-99f8-41bd-ad52-bf4f6ffd8f6e 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026