Medical Devices & Diagnostics · LP-208
Blood pressure monitor Medical device
Device / diagnostic development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-208Medical Devices & Diagnostics
- Product type
- Blood pressure monitorMedical 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-208
- Product type
- Blood pressure monitor
- Device presentation
- Medical device
- Configuration / specification
- Automatic upper-arm device
- Proposed pack
- Retail carton
- Portfolio category
- Medical Devices & Diagnostics
About Blood pressure monitor
An automatic upper-arm blood pressure monitor estimates systolic and diastolic pressure using a cuff and an electronic measurement system. It is a medical device rather than a medicine. Reliable results depend on device performance, an appropriate cuff and correct measurement conditions. A generic description does not establish clinical validation, suitability for pregnancy or irregular heart rhythms, or accuracy across every arm size.
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
Blood-pressure monitoring may support clinical assessment and follow-up at home or in a professional setting when the device is intended for that use. Repeated measurements and clinical interpretation are more informative than an isolated reading. Symptoms and wider cardiovascular risk also matter. The proposed catalogue item has no named model, so specific claims about connectivity, memory, detection algorithms or patient populations remain unverified.
Important safety considerations
An unsuitable cuff, poor positioning, movement, clothing or an unvalidated device can produce misleading values. Irregular rhythms and certain patient characteristics may affect performance. Users should not change medication solely on an unexpected reading without following their agreed clinical plan. Severe symptoms require medical assessment even if the device gives an apparently reassuring result. Shared-use equipment must have appropriate cleaning and maintenance procedures.
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 identifies an automatic upper-arm device but no model or cuff range. Verify validation evidence, intended population, cuff options, power system, measurement range, software features and instructions before publishing performance claims.
Follow the named device’s instructions for cleaning, storage, battery replacement and periodic performance checks. Protect the cuff and tubing from damage. Retain the model and serial information, and obtain service advice when readings are inconsistent or the unit is damaged.
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 model-level authorization, independent clinical validation where relevant, appropriate cuff sizing and user training. Establish service, calibration or checking arrangements and complaint traceability.
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
- Blood pressure monitor
- Presentation
- Medical device
- Catalogue configuration
- Automatic upper-arm device
- Catalogue pack
- Retail carton
- Portfolio category
- Medical Devices & Diagnostics
Layer 02
Unresolved product-specific fields
- P024 — “Automatic upper-arm device” is a generic description, not a model-specific blood-pressure-monitor dossier. Cuff range, measurement method, validated accuracy, display/memory functions, power source and intended-use population are not established.
- No FDA authorization, CE marking, ISO validation or other conformity/performance claim is made from the generic catalogue entry.
- 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 safety communication: unauthorized blood-pressure measurement devicesgovernment medical-device safety communication
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-208, 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-208.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.