Identity
- Trade Name
- Hi-Loo EUDAMEDEtac Supply Center AB FDA UDI
- Generic Name
- Raised toilet seat FDA UDI
- Device Name
- With brackets, 10cm FDA UDI
- Model / Reference
- Toilet Aids EUDAMED80301105 EUDAMEDHi-Loo FDA UDI
- Description
- With brackets, 10cm FDA UDI
Identifiers
- Catalog Number
- 80301105 FDA UDI
- Primary DI / UDI-DI
- 07320450001659 EUDAMEDFDA UDI
- Basic UDI-DI
- 73204510013X EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y091215 TOILET SEATS, RAISED EUDAMED
- GMDN Term
- Raised toilet seat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Hi-Loo by Etac Supply Center Ab — 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 | 73204510013X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etac Supply Center AB
- EUDAMED SRN
- SE-MF-000001230
Sources (2)
- EUDAMED 118c9733-6b24-4707-b4e5-4ba2d224e0cb 61 fields · synced Jun 18, 2026
- FDA UDI 2d569ed7-47e5-47b5-9563-888c2a3134c7 34 fields · synced May 30, 2026