Identity
- Trade Name
- Q Untergestell, schwarz EUDAMEDQ-chassis, hi/low indoor base, pedal op. FDA UDI
- Generic Name
- Assistive pushchair FDA UDI
- Device Name
- Untergestelle EUDAMED
- Model / Reference
- 9800066666000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04034089054094 EUDAMEDFDA UDI
- Basic UDI-DI
- 4034089UntergestelleLX EUDAMED
- Direct Marketing DI
- 04034089054094 EUDAMED
- FDA Product Code
- KNO FDA UDI
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
- GMDN Term
- Assistive pushchair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Q Untergestell, schwarz by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KG — Class I — CE/MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4034089UntergestelleLX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- DE-MF-000006303
Sources (2)
- EUDAMED b6d4a672-5ef5-4b71-9363-7b5eacdb2241 61 fields · synced Oct 6, 2026
- FDA UDI 894bab86-21c2-4123-a8b9-dcd56a9de737 32 fields · synced May 29, 2026