← Back to catalogue
Waterbath
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MTRH1500EXModel Thermoplastic Devices
by Medtec LLC
Identity
- Trade Name
- Waterbath FDA UDI
- Generic Name
- Thermoplastic-moulding water bath FDA UDI
- Device Name
- 230V FDA UDI
- Model / Reference
- MTRH1500EX EUDAMEDFDA UDIThermoplastic Devices EUDAMED
- Description
- 230V FDA UDI
Identifiers
- Catalog Number
- MTRH1500EX FDA UDI
- Primary DI / UDI-DI
- 00841439111345 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0003R13AH EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
- GMDN Term
- Thermoplastic-moulding water bath FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 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
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermoplastic-moulding water bath
Waterbath by Medtec LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Thermoplastic-moulding water bath.
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · Class I
- Thermasplint — Whitehall Manufacturing Co · 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
- Medtec LLC
Sources (2)
- FDA UDI 8aa383b3-808b-416c-8773-23fe1a90ce9e 35 fields · synced Jul 11, 2026
- EUDAMED 67291bbd-17d7-4a11-bc1b-2515b2fb5f6d 61 fields · synced Jul 11, 2026