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Advantage chassis Size 2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9800064013000Ref 9800064023000
Identity
- Trade Name
- Advantage chassis Size 2 EUDAMEDAdvantage chassis Size 2 Crash EUDAMEDEASyS Advantage chassis size 2 FDA UDI
- Generic Name
- Assistive pushchair FDA UDI
- Device Name
- Untergestelle EUDAMED
- Model / Reference
- 9800064013000 EUDAMED9800064023000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04034089052519 EUDAMED04034089052540 EUDAMEDFDA UDI
- Basic UDI-DI
- 4034089UntergestelleLX EUDAMED
- Direct Marketing DI
- 04034089052519 EUDAMED04034089052540 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y122703 PUSHCHAIRS EUDAMED
- GMDN Term
- Assistive pushchair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Advantage chassis Size 2 by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KG — Class I — 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 (3)
- EUDAMED 1bb7b4fe-ea25-4756-93f2-941c7a0f2d72 61 fields · synced Oct 6, 2026
- EUDAMED 20bd72a8-0442-4a6e-9f60-c8ceb7c141c4 61 fields · synced May 18, 2026
- FDA UDI 3a0ceb01-901f-4888-9a57-c8ab86c94706 32 fields · synced May 30, 2026