Identity
- Trade Name
- Vela Treatment Chair EUDAMEDVELA Rumba FDA UDI
- Generic Name
- Haemodialysis chair, electric FDA UDI
- Device Name
- Vela Rumba EUDAMEDTreatment chair for adult people FDA UDI
- Model / Reference
- 87215 EUDAMED87215 Treatment chair FDA UDI
- Description
- Treatment chair for adult people FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714339123358 EUDAMEDFDA UDI
- Basic UDI-DI
- 57143390007PU EUDAMED
- Direct Marketing DI
- 05714339123358 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Z12099003 HOSPITAL BEDS OR ARMCHAIR SCALES FOR DIALYSIS EUDAMED
- GMDN Term
- Haemodialysis chair, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
VELA Rumba by Vermund Larsen A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vermund Larsen A/S
Sources (2)
- FDA UDI 86ab7df4-68fc-4083-a34d-bd04c50a3e00 34 fields · synced Jul 29, 2026
- EUDAMED b639d910-2d4e-448d-bc6e-d8f5f0ac45fe 61 fields · synced Jul 29, 2026