Identity
- Trade Name
- Recumbent Ergometer ergoselect 600 P FDA UDI
- Generic Name
- Bicycle ergometer FDA UDI
- Model / Reference
- 1615510 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059358001647 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
Category: Bicycle ergometer
Recumbent Ergometer ergoselect 600 P 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 b768c944-b80b-4004-8c5e-9d81b7c7a338 32 fields · synced Jun 1, 2026