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Comfortline HI LO 230V, 50mm drain, Reverse installation
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 05194008
Identity
- Trade Name
- TR Comfortline Bath, reverse installation, 50 mm drainage EUDAMEDComfortline HI LO 230V, 50mm drain, Reverse installation FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- Bathing devices EUDAMEDComfortline HI LO 230V, 50mm drain, Reverse installation FDA UDI
- Model / Reference
- 05194008 EUDAMEDFDA UDI
- Description
- Comfortline HI LO 230V, 50mm drain, Reverse installation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350016061698 EUDAMEDFDA UDI
- Basic UDI-DI
- 7350016060206C EUDAMED
- FDA Product Code
- KTC FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Hydrotherapy bath/tank FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5125 FDA UDI
- Market of Registration
- Lithuania 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
Category: Hydrotherapy bath/tank
Comfortline HI LO 230V, 50mm drain, Reverse installation by Tr Equipment AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Hydrotherapy bath/tank.
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- Primo — Arjohuntleigh, Inc. · Class II
- Haltegriff Edelstahl, 40 cm — Ludwig Bertram GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tr Equipment AB
Sources (2)
- FDA UDI afceba6d-e939-452c-aa24-4f3c9adf1c88 33 fields · synced Sep 17, 2026
- EUDAMED 11a49b12-0a7a-4c07-8834-4c14c8678c62 61 fields · synced Sep 17, 2026