Identity
- Trade Name
- Orca EUDAMEDAquatec XL with white cover FDA UDI
- Generic Name
- Basic toilet seat FDA UDI
- Device Name
- Orca EUDAMEDAquatec XL with white cover FDA UDI
- Model / Reference
- 1573862 EUDAMEDFDA UDI
- Description
- Aquatec XL with white cover FDA UDI
Identifiers
- Catalog Number
- 1573862 FDA UDI
- Primary DI / UDI-DI
- 04028698125238 EUDAMEDFDA UDI
- Basic UDI-DI
- 4028698OrcaDT EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- V08050303 BATH LIFTS EUDAMED
- GMDN Term
- Basic toilet seat 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Orca by Invacare GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 4028698OrcaDT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (2)
- EUDAMED a4b8f3d4-dceb-4fd0-ba82-5851b686aafb 61 fields · synced Jul 15, 2026
- FDA UDI 5d4d2656-9f05-4a8c-b3a3-278e1f196fac 35 fields · synced May 30, 2026