Identity
- Trade Name
- NexTemp SUT C Ultra Symbols OW EUDAMEDNexTemp FDA UDI
- Generic Name
- Liquid-crystal patient thermometer, single-use FDA UDI
- Device Name
- Clinical Thermometer EUDAMEDNexTemp Ultra C Single-use Clinical Thermometer FDA UDI
- Model / Reference
- 8200 EUDAMEDFDA UDI
- Description
- NexTemp Ultra C Single-use Clinical Thermometer FDA UDI
Identifiers
- Catalog Number
- NXT Ultra C FDA UDI
- Primary DI / UDI-DI
- 00016944401100 EUDAMEDFDA UDI
- Basic UDI-DI
- 016944NXTWT EUDAMED
- Unit of Use DI
- 10016944401107 EUDAMED
- FDA Product Code
- FQZ FDA UDI
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
- GMDN Term
- Liquid-crystal patient thermometer, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.2900 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.00150 Pound FDA UDI
NexTemp SUT C Ultra Symbols OW by Medical Indicators — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 016944NXTWT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medical Indicators
- EUDAMED SRN
- US-MF-000018094
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED c5d1e47c-d064-450f-8306-280ab3fd992a 61 fields · synced Jul 17, 2026
- FDA UDI 4b80206e-1c4a-46f1-bdb2-fd346bb489c7 36 fields · synced May 30, 2026