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Ecoline with mixer, 50 MM DRAIN, H=80 CM
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 0521040-R
Identity
- Trade Name
- TR 4000 Shower trolley, Removable battery, Atlas EUDAMEDEcoline with mixer, 50 MM DRAIN, H=80 CM FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- Showering devices EUDAMEDEcoline with mixer, 50 MM DRAIN, H=80 CM FDA UDI
- Model / Reference
- 0521040-R EUDAMED05194032 FDA UDI
- Description
- Ecoline with mixer, 50 MM DRAIN, H=80 CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350016060035 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500160601069 EUDAMED
- FDA Product Code
- KTC FDA UDI
- EMDN Code
- Y093312 SHOWER STRETCHERS EUDAMED
- GMDN Term
- Hydrotherapy bath/tank FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5125 FDA UDI
- Market of Registration
- Netherlands 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
Ecoline with mixer, 50 MM DRAIN, H=80 CM by Tr Equipment AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hydrotherapy bath/tank.
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- CRYSTAL ELECTRIQUE — France Reval · Class I
- Harmony Bath — Arjohuntleigh, Inc. · Class II
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- Primo — Arjohuntleigh, Inc. · Class II
- Primo Ferro — Arjohuntleigh, Inc. · Class II
- 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 5636f4ed-edaa-4548-ab91-676dd7bf7265 33 fields · synced Jul 19, 2026
- EUDAMED 3fbd8f79-6cd8-4a85-810f-8727d837d5fb 61 fields · synced Jul 19, 2026