Identity
- Trade Name
- Flex EUDAMEDEtac Supply Center AB FDA UDI
- Generic Name
- Bath hand rail FDA UDI
- Device Name
- Grab rail wall mounted FDA UDI
- Model / Reference
- Grab Rails and Handgrips EUDAMED81707310 EUDAMEDFlex FDA UDI
- Description
- Grab rail wall mounted FDA UDI
Identifiers
- Catalog Number
- 81707310 FDA UDI
- Primary DI / UDI-DI
- 07320451384706 EUDAMEDFDA UDI
- Basic UDI-DI
- 732045102247 EUDAMED
- FDA Product Code
- IKX FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Bath hand rail 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hydrotherapy bath/tank
Flex by Etac Supply Center Ab — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 732045102247 | 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 ce3ca356-1f40-4e33-a984-acd27c9bb196 61 fields · synced Jun 18, 2026
- FDA UDI caee0ca7-ae88-4b2f-b870-6ae2d92d7a66 34 fields · synced May 30, 2026