Identity
- Trade Name
- Kinetigram EUDAMEDFDA UDI
- Generic Name
- Biomechanical function analysis/rehabilitation software FDA UDI
- Device Name
- Kinetigram EUDAMEDKinetigram is a cloud-based software platform that provides upper mobility assessment FDA UDI
- Model / Reference
- 200-00201 EUDAMEDv2 FDA UDI
- Description
- Kinetigram is a cloud-based software platform that provides upper mobility assessment FDA UDI
Identifiers
- Catalog Number
- 200-00201-DO-01 FDA UDI
- Primary DI / UDI-DI
- 00860007286506 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600072865kinetigramTD EUDAMED
- FDA Product Code
- KQX FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Biomechanical function analysis/rehabilitation software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1500 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kinetigram by Bioniks — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600072865kinetigramTD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bioniks
- EUDAMED SRN
- US-MF-000044597
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 65eaea8f-172d-494a-a5f1-7b2c47a2c3f2 61 fields · synced Aug 1, 2026
- FDA UDI 916d3794-342c-489a-8542-103a3902fd19 35 fields · synced May 29, 2026