Medical Devices & Diagnostics · LP-210
Digital thermometer Medical device
Device / diagnostic development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-210Medical Devices & Diagnostics
- Product type
- Digital thermometerMedical device
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Product-type reference
Record identity and reference background.
- Portfolio reference
- LP-210
- Product type
- Digital thermometer
- Device presentation
- Medical device
- Configuration / specification
- Digital device
- Proposed pack
- Retail carton
- Portfolio category
- Medical Devices & Diagnostics
About Digital thermometer
A digital thermometer measures temperature at a specified anatomical site using a particular sensor and algorithm. It is a medical device and does not diagnose the cause of fever. Different thermometer designs and measurement sites are not automatically interchangeable. The generic catalogue description does not establish whether the proposed device is contact, infrared, oral, axillary or another type.
How to read this profile
Scientific information relates to the device or diagnostic type. It is not approved Luang Pharma labelling, a clinical recommendation, or evidence of equivalence to a referenced product. Multiple strengths or presentations represent separate proposed variants and must not be treated as interchangeable.
02 · Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Intended-use context
Temperature is interpreted with symptoms, age, exposure history and the clinical setting. A single value should not override concerning symptoms or delay assessment of a seriously unwell person. Measurement technique and site affect interpretation, especially in children. A device authorized for one age group or site may not be appropriate for another. No accuracy range, reading speed or fever-detection claim is established for the unnamed candidate.
Important safety considerations
An incorrect measurement site, poor positioning, a damaged sensor or unsuitable environmental conditions can give misleading readings. Shared probes can transmit infection if cleaning or protective-cover procedures are inadequate. Small batteries and components must be kept away from children. Do not use a device at an anatomical site that its instructions do not permit. Seek clinical assessment for significant symptoms regardless of a seemingly normal temperature.
These are selected considerations, not a complete list. Use the current instructions or approved label for the exact authorised product and seek appropriate professional advice.
Presentation, handling and storage
The source specifies only a digital device. Confirm measurement technology, permitted sites, age groups, accuracy and range, cleaning compatibility, power source and accessories. These are model-level attributes and must not be invented from a generic retail-carton description.
Use only the cleaning and disinfection methods permitted for the exact thermometer. Check probe condition and battery status, and follow any required environmental acclimatization. Keep model information and instructions with the device so measurement sites and cleaning rules remain clear.
Final composition, instructions, shelf life and storage conditions are not established by this portfolio entry. They must come from the controlled documentation for the specific product.
Points for professional review
Confirm the intended clinical setting and user population, model authorization and performance evidence. Provide the exact instructions, cleaning process and after-sales support arrangements.
03 · Product enquiry
Documentation & regulatory status
Evidence status
What is established — and what remains open
This record has received an editorial evidence-layer review. The review separates catalogue facts from unresolved product-specific fields and external context; it is not medical, regulatory or market-authorisation approval.
Layer 01
Controlled catalogue facts
- Device / diagnostic type
- Digital thermometer
- Presentation
- Medical device
- Catalogue configuration
- Digital device
- Catalogue pack
- Retail carton
- Portfolio category
- Medical Devices & Diagnostics
Layer 02
Unresolved product-specific fields
- P024 — “Digital device” does not establish whether this thermometer is oral, axillary, rectal, tympanic, infrared, contact or non-contact, nor its measurement range, accuracy, response time or intended-use population.
- No model-specific conformity, calibration, clinical accuracy or fever-threshold claim is supported by the catalogue record.
- Approved indication, patient eligibility and dosing or test interpretation are not established by this portfolio record.
- Registration/authorization, manufacturing or site status, supply availability, storage conditions and shelf life remain product- and market-specific evidence items.
Layer 03
Attributed external context
- FDA: Non-contact infrared thermometers — benefits, limitations and proper usegovernment medical-device guidance
These references provide scientific or regulatory context only. They are not Luang Pharma product labelling, registration, manufacturing evidence, equivalence evidence or confirmation of supply.
Layer 04
Documents required to close the record
- Exact manufacturer/model specification and IFU establishing intended use, technical configuration, performance limits, accessories/compatibility, warnings, storage, shelf life and sterilization where applicable.
- Destination-market device/IVD classification and authorization/conformity evidence for the exact model; generic FDA/WHO references are not evidence for the Luang record.
- Model-specific quality/performance verification and current packaging/label artwork before any public certification, accuracy, sterility or compatibility claim.
- Manufacturing/supply-status evidence before any claim that the device is produced, stocked, registered or available through Luang Pharma.
For LP-210, identify the destination country, intended professional use, proposed presentation and the role of your organisation. The appropriate supply route and available documentation must be confirmed for that case.
- Confirm the legal entity, manufacturing site and authorised scope for the proposed supply chain.
- Confirm device classification, intended use, conformity evidence and local import requirements.
- Request relevant product information, specifications and supporting evidence through the company contact.
- Confirm storage, transport, traceability, complaints and safety-reporting responsibilities before any agreement.
The public catalogue extends beyond the initial planned facility modules. A listing does not mean that the dosage form is installed, qualified or licensed at Boten.
04 · External sources
Sources and further reading
External sources are provided for reference. Their authors do not endorse Luang Pharma, and another product’s authorisation does not transfer to this portfolio record. Source availability and wording can change.
Professional enquiries
Request product-specific evidence for LP-210.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.