Identity
- Trade Name
- ergoselect 1 FDA UDI
- Generic Name
- Bicycle ergometer FDA UDI
- Model / Reference
- 195001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059358001821 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Bicycle ergometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 1280 Millimeter FDA UDILength — 1000 Millimeter FDA UDIWidth — 440 Millimeter FDA UDIWeight — 55 Kilogram FDA UDI
Category: Bicycle ergometer
ergoselect 1 by ergoline GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bicycle ergometer.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ergoline GmbH
Sources (1)
- FDA UDI 071c9d2b-5b8c-4f92-a824-2a5f85a368d1 34 fields · synced Jun 8, 2026