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面向监管机构 · 合规数据基础设施 · 实时监测

让合规可执行。
让每台设备可见。

XEO为监管机构提供覆盖电子烟设备全生命周期的硬件级数据支持能力。审计追踪和加密设备认证，内置于每台设备，而非事后以软件形式加装。

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Configurable
Reporting Interval
Hash-chained
Append-only records, daily signed root
2
监管框架
AEAD
端到端加密
REAL-TIME MONITORING
HASH-CHAINED AUDIT TRAILS
HARDWARE-ENFORCED
FDA PMTA COMPATIBLE
BUILT FOR EU TPD ARTICLE 20
CRYPTOGRAPHIC AUTHENTICATION
POST-MARKET MONITORING
REAL-TIME MONITORING
HASH-CHAINED AUDIT TRAILS
HARDWARE-ENFORCED
FDA PMTA COMPATIBLE
BUILT FOR EU TPD ARTICLE 20
CRYPTOGRAPHIC AUTHENTICATION
POST-MARKET MONITORING
执法漏洞

XEO解决的
三大挑战

当前的执法机制依赖于销售点控制，产品一旦离店便失效。XEO将监管监督延伸到设备层面。

01

售后执法真空

销售点年龄验证在购买后提供零数据支持能力。设备通过二级市场、社交分享和盗窃自由流向未成年用户。没有设备级控制，监管机构在初始交易后无法阻止未授权使用。

02

假冒产品泛滥

不受监管的假冒设备代表着日益增长的安全隐患，直接挑战监管权威。没有加密设备认证，执法机构在检查、供应链和边境均无法区分合法产品与危险假冒品。

03

市场监管数据缺口

监管机构缺乏关于设备使用模式、人群级消费趋势和违规行为的实时数据。执法行动依赖回顾性报告、投诉和人工检查。这些工具不足以应对现代电子烟（ENDS，电子尼古丁输送系统）市场的规模。

合规证明

默认
支持监管审查

Records are append-only and hash-chained, with a daily signed root that can be verified on request. 无需手动文档。无自报数据。按需可用。

  • 设备认证日志

    每次激活尝试均记录时间戳、地理位置和生物识别验证结果，written into an append-only log with a daily signed root。抗篡改，托管于企业级、安全加固基础设施。

  • 年龄验证审计追踪

    从初始身份核查到生物识别重新认证的完整验证链。每个验证事件关联设备ID和结果状态。

  • 执法行动记录

    每项合规干预的文档记录：设备锁定、地理限制执行、授权撤销和假冒检测事件。

加密完整性

Records are append-only and hash-chained, with a daily signed root that can be verified on request.记录的事后篡改、回溯日期或伪造均可检测。

Regulatory agencies receive platform-generated records, not self-reported claims.

数据采用AEAD加密，托管于企业级、安全加固基础设施，通过角色化监管门户访问。

XEO的硬件强制认证由已授权专利提供保障，而非仅仅是架构声明。EP 4,007,503 · US 12,622,469 · CA 3,190,264 →
监测能力

设备监测

XEO使每台设备能够报告使用、验证和合规数据。监测使用模式、识别异常并支持执法决策，全部来自集中化监测仪表板。

// Real-Time Telemetry

设备遥测

每台活跃设备的加密数据流。实时监测整个设备群体的激活事件、使用频率、会话模式和消费指标。

// Geographic Enforcement

地理围栏合规区域

定义设备可以或不可以运行的地理边界。A fix inside a restricted zone records a violation and raises an alert; suspension is an operator action or a configured rule. 可按法规、地区、设备类别配置。

// Anomaly Detection

自动违规警报

Rule-based anomaly detection on every frame 识别可疑使用模式、反复认证失败、未授权修改尝试和地理限制违规。可配置警报阈值和升级工作流。

// Counterfeit Detection

加密设备验证

Every XEO device carries a unique cryptographic identity, checked against the registry each time an authorisation is issued. Counterfeit and refilled pods are identified from usage patterns and reported. Cryptographic pod authentication — in development.

框架兼容性

为您的
监管体系构建

XEO的架构设计为同时支持多个监管框架。A single infrastructure layer provides jurisdiction-specific age rules and device authentication, with one regulatory report set on top.

🇺🇸
FDA PMTA
美国

Device-level evidence for a Premarket Tobacco Product Application: access-restriction documentation, age-verification records and post-market monitoring data.

XEO maintains a Tobacco Product Master File with the FDA and grants right of reference by Letter of Authorization. A master file is not reviewed by the FDA on its own. The applicant remains the responsible manufacturer.

🇪🇺
EU TPD 第20条
欧盟

Tobacco Products Directive requirements — European platform in preparation. Device and component description for the manufacturer's Article 20 notification. Usage aggregates by region and device type. A usage-weighted HPHC exposure model, which is not laboratory emissions data.

监管参考资料： FDA PMTA指南 · EU TPD — 电子烟 · EU追踪追溯 · GDPR
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数据访问

监管
报告工具

为监管机构专门构建的数据访问基础设施。角色化权限、实时仪表板。

监管访问门户

为授权监管人员提供的专用网络门户。角色化访问控制、多因素认证。每一次 state-changing 操作均以 actor、resource 和时间戳记录于 append-only 日志，hash-chained，每日一个 signed root。每一次数据导出均被记录。

角色化访问

实时仪表板

跨设备群体的实时合规指标。可配置视图涵盖年龄验证率、地理合规、假冒检测和执法行动跟踪。

实时监测

Reporting

Thirteen regulatory reports: device lifecycle, usage and post-market surveillance aggregates, geographic compliance, counterfeit and supply chain, safety and anomalies, compliance violations, recall and action log, adverse events, HPHC exposure, sales reconciliation, youth access, age verification, and the periodic FDA data feed. Each exports as CSV, JSON or XLSX, and can be delivered automatically on a daily, weekly or monthly schedule. Regulatory packages are issued as signed PDF with a per-file checksum manifest.

Export

人群分析

跨人口统计、地理和设备类型的汇总使用统计。识别消费趋势、高风险人群和市场模式，为循证政策决策提供依据。

Aggregates only

Licensee API Access

Read-only regulator portal behind multi-factor authentication. Since 1.9.1, licensee API keys give machine access to the licence holder's own data packages. No programmatic access to the verification database, no customs integration.

REST API

事件响应

关键合规事件的实时警报系统。可配置升级工作流、即时设备锁定能力和多机构执法操作的协调响应工具。

实时警报
监管机构常见问题

常见
问题

XEO如何实现对市场中设备的实时监测？

+
XEO将加密遥测模块直接嵌入设备硬件。这些模块持续向集中化合规仪表板报告使用模式、激活事件和地理数据。监管机构可以接收异常行为和授权范围外激活事件的实时提醒。

XEO提供哪些支持监管审查的文档？

+
XEO生成验证记录，包括设备认证日志、年龄验证审计追踪和上市后监测数据。所有记录均加密签名、带时间戳，格式化为可直接用于监管审查和执法程序。

监管机构能否直接访问XEO数据？

+
可以。XEO提供专用监管访问门户，具有角色化权限、实时仪表板和自动化报告。监管机构可查询设备群体、审查合规指标并接收可配置警报。所有访问均记录且符合GDPR。Reports export in machine-readable formats for ingestion into an agency's own systems. A direct system-to-system integration would be a bespoke project.

XEO如何处理数据隐私和GDPR合规？

+
年龄核验在云端执行：护照数据及人脸图像由网页应用上传至后端完成处理，且绝不会下发至设备。指纹数据永不离开传感器：指纹模板保存在指纹传感器的安全硬件内部，不存储原始指纹图像；即便是我方自有固件也无法读取模板，仅可获得比对结果。恢复出厂设置或远程操作均可将该模板清除。Telemetry carries no personal data in the payload. Because the platform holds the link between a device and its verified owner, the link that makes a recall reachable, telemetry is pseudonymous rather than anonymous. Regulators and manufacturers receive aggregates only. Retention follows the deployment region: telemetry is kept four years in the US configuration, matching the FDA record-keeping period, and two years in the EU configuration, with location data kept ninety days. 基于角色的访问配合完整审计日志。XEO在企业级、安全加固基础设施上保持GDPR和CCPA合规。

XEO目前支持哪些监管框架？

+
XEO支持FDA PMTA和TPMF（美国）。The platform provides a periodic report data feed under 21 CFR 1114.41, adverse event data packages on a 15-day clock from awareness, recall effectiveness evidence, and a reporting calendar per licensee, as data packages in JSON, CSV and PDF.

XEO如何帮助识别和打击假冒设备？

+
每台XEO设备携带通过抗篡改验证注册表验证的加密身份。The platform records firmware distribution to each licensee in a tamper-evident ledger, and reconciles device activations against the manufacturer's own imported sales data by territory, channel and distributor.
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