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TR1700 HI LO 230V incl. Mixer and shower
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 05191701
Identity
- Trade Name
- TR 1700 Bath EUDAMEDTR1700 HI LO 230V incl. Mixer and shower FDA UDIHilo-Bath TR 1700 TMV2, 40 MM DRAINAGE FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- Bathing devices EUDAMEDTR1700 HI LO 230V incl. Mixer and shower FDA UDIHilo-Bath TR 1700 TMV2, 40 MM DRAINAGE FDA UDI
- Model / Reference
- 05191701 EUDAMEDFDA UDI05191743 FDA UDI
- Description
- TR1700 HI LO 230V incl. Mixer and shower FDA UDIHilo-Bath TR 1700 TMV2, 40 MM DRAINAGE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350016060141 EUDAMEDFDA UDI07350016061926 FDA 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
- 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
Category: Hydrotherapy bath/tank
TR1700 HI LO 230V incl. Mixer and shower 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tr Equipment AB
Sources (3)
- FDA UDI 198e832a-2394-4873-8a0a-38056b9ed1ac 33 fields · synced Oct 6, 2026
- FDA UDI 44d1ae6b-773b-4602-8d9c-5bbe173bd008 33 fields · synced May 26, 2026
- EUDAMED 05cdaf1f-fcbb-4425-a2fa-493aba40c4fb 61 fields · synced Jul 13, 2026