Bath Liner
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Bath Liner FDA UDI
- Generic Name
- Thermoplastic-moulding water bath FDA UDI
- Device Name
- 48 x 61cm FDA UDI
- Model / Reference
- MTCBPLLG EUDAMEDFDA UDIThermoplastic Devices EUDAMED
- Description
- 48 x 61cm FDA UDI
Identifiers
- Catalog Number
- MTCBPLLG FDA UDI
- Primary DI / UDI-DI
- 00841439104101 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0003R01AA EUDAMED
- 510(k) Number
- K933227 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
- GMDN Term
- Thermoplastic-moulding water bath FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 30 Inch FDA UDI
Category: Thermoplastic-moulding water bath
Bath Liner by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Thermoplastic-moulding water bath.
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- Thermasplint — Whitehall Manufacturing Co · Class I
Cleared under the same submission
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- Headrest — Medtec LLC
- Headrest — Medtec LLC
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- Shim — Medtec LLC
- Shim — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI 49dcaa69-20cb-4414-a757-35749eaffc59 37 fields · synced Jun 19, 2026
- EUDAMED 0120bbaa-35d4-4bd0-a383-32de4a2546a5 61 fields · synced Jun 19, 2026