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Zeno Electronic Walkway
EUDAMEDFDA UDIClass I (EU MDR)
Ref Z418-220 ALL SIZESModel PLATINUM
Identity
- Trade Name
- ZENO ELECTRONIC WALKWAY EUDAMEDFDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Device Name
- ZENO ELECTRONIC WALKWAY EUDAMEDThe Zeno Electronic Walkway with PKMAS Software deliver Gait Analysis measurements that describe the performance, style, effectiveness and efficiency of walking without referring to its etiology. FDA UDI
- Model / Reference
- PLATINUM EUDAMEDFDA UDIZ418-220 ALL SIZES EUDAMED
- Description
- The Zeno Electronic Walkway with PKMAS Software deliver Gait Analysis measurements that describe the performance, style, effectiveness and efficiency of walking without referring to its etiology. FDA UDI
Identifiers
- Catalog Number
- Z418-220 ALL SIZES FDA UDI
- Primary DI / UDI-DI
- 00860252000704 EUDAMEDFDA UDI
- Basic UDI-DI
- 08602520007ZENO_WALKWAYZR EUDAMED
- Direct Marketing DI
- 00860252000704 EUDAMED
- FDA Product Code
- JFC FDA UDI
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.1600 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
Yes
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Zeno Electronic Walkway by Zenometrics Llc — 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 | 08602520007ZENO_WALKWAYZR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zenometrics Llc
- EUDAMED SRN
- US-MF-000016122
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED a61f3b90-282d-4163-ac78-90a0940938d2 61 fields · synced Oct 6, 2026
- FDA UDI 8146c533-1e42-4900-854d-8bac76dae0fa 35 fields · synced May 27, 2026