Identity
- Trade Name
- Hi-Loo Fixed EUDAMEDEtac Supply Center AB FDA UDI
- Generic Name
- Raised toilet seat FDA UDI
- Device Name
- Fixed, 6cm, arm support FDA UDI
- Model / Reference
- Toilet Aids EUDAMED80301316-2 EUDAMEDHi-Loo FDA UDI
- Description
- Fixed, 6cm, arm support FDA UDI
Identifiers
- Catalog Number
- 80301316-2 FDA UDI
- Primary DI / UDI-DI
- 07320451358189 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 Fixed 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 a9910884-0363-449e-9798-43661b190a98 61 fields · synced Jul 13, 2026
- FDA UDI 21b57d4a-ea40-4cf1-8f87-0df321fd3e3e 34 fields · synced May 30, 2026