Identity
- Trade Name
- K-Bubble EUDAMEDKForce Bubble FDA UDI
- Generic Name
- Back/leg/chest dynamometer, electronic FDA UDI
- Device Name
- KForce Bubble EUDAMEDK Bubble is a pneumatic sensor allowing to work your strength with convenient inflatable tools. FDA UDI
- Model / Reference
- MP.06.04.FN EUDAMEDK Bubble V3 FDA UDI
- Description
- K Bubble is a pneumatic sensor allowing to work your strength with convenient inflatable tools. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770011995455 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03770011995455 EUDAMED
- FDA Product Code
- LBB FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Back/leg/chest dynamometer, electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1240 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
K-Bubble by Kinvent Biomecanique — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03770011995455 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- KINVENT Biomecanique
- EUDAMED SRN
- FR-MF-000031884
Sources (2)
- EUDAMED 26be826c-e602-4f38-b1e5-be7de4de37c0 61 fields · synced Jun 19, 2026
- FDA UDI 2667b8c4-d01c-4e1a-8d35-f67aca0e5d78 35 fields · synced May 29, 2026