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 EUDAMED81707220 EUDAMEDFlex FDA UDI
- Description
- Grab rail wall mounted FDA UDI
Identifiers
- Catalog Number
- 81707220 FDA UDI
- Primary DI / UDI-DI
- 07320451384737 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
Flex 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 | 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 c0c4aef3-b4f3-4621-a0a2-1969beb4e6b7 61 fields · synced Jul 29, 2026
- FDA UDI 5eda9a10-e4eb-4996-9356-d337519ae692 34 fields · synced May 29, 2026