udi-db-submission-check

依据 NMPA UDI 规则、FDA 21 CFR 830/GUDID、EU MDR Art 27-29/EUDAMED，对 UDI 提交库别、时机与必填字段做确定性判定，输出 JSON IR（result/rc/error_code）与风险提示；仅作决策支持，输入不足从严提示，不覆盖特殊器械情形，需人工复核官方文本。

zhaoxinghua09-cell

热度 23.99

最近更新 2026-10-17 07:45:02

分类：安全依赖：纯提示词应用场景：法律文档

安装技能

复制下面的话术发给你的 Agent，它会通过 secure-skills 检索并安装该技能。

执行命令安装此 skill： npx secure-skills-cli add zhaoxinghua09-cell/udi-db-submission-check

Metadata

name: udi-db-submission-check
title: UDI Database Submission Compliance Checker
slug: udi-db-submission-check
display_name: UDI 数据库提交合规判定器
display_name_en: UDI Database Submission Compliance Checker
version: 1.0.1
license: MIT
allowed-tools: Read, Glob, Grep, Bash, Write, WebFetch
author: SynomosAI (LGD initiative)
copyright: SynomosAI
category: medtech-reg
platforms: ["windows","macos","linux"]
platform_compatibility: ["windows","macos","linux"]
description: UDI 数据库提交合规判定器——UDI 格式对了，但该传哪个库、什么时候传、必填哪些字段，漏传或漏维护上市即违规（零依赖规则判定，JSON IR，rc=0/1/2）。
description_zh: UDI 数据库提交合规判定器：UDI 码格式对了，但该传哪个库、何时传、必填哪些字段需判定；漏传/漏维护上市即违规（零依赖规则判定，JSON IR，rc=0/1/2）。
description_en: UDI database submission compliance checker: given the UDI string, which database, when, and which fields are mandatory; missing or lapsed submission is non-compliant at market launch (zero-dependency rule determination, JSON IR, rc=0/1/2).
classification: {"skillhub":["medtech-reg","medical-device","udi"],"clawhub":["productivity","data-analytics","development"],"iso_25010":["Functional suitability"]}
read_when: ["需判定 UDI 数据该提交到哪个库（NMPA/GUDID/EUDAMED）","不清楚提交时机与必填字段清单","需确认漏传/漏维护是否构成上市违规"]
risk_tier: medium
risk_rationale: 调用 API/读写文件/本地执行，最小权限，密钥走 Secret；若实际涉对外代执行(push/发布/发送/上架)须人工复评，改 high 并走负责人批准。
tags: ["udi-db-submission-check","医疗器械合规","UDI","medtech-reg"]
ai_protocol: true
spec: usk/1.0
interface: {"type":"prompt","entry_point":"SKILL.md","runtime":"none","call_pattern":"prompt"}
output_schema: {"stdout":"structured JSON IR","exit_code":"rc=0 ok / rc=1 warning / rc=2 bad input"}
changelog: 1.0.1: Bilingual rewrite (EN-first) + read_when/classification; all branding/copyright refs neutralized; 1.0.0 initial

凡自治之物 · LGD 治理学 · 创造术家族｜评测协议：skill-quality-gate

English

UDI Database Submission Compliance Checker

When to use

The UDI string format is correct, but which database, when, and which fields are mandatory are unclear; a missing or lapsed submission is non-compliant at launch.

What it is

A zero-dependency, deterministic rule determination: pass known conditions as parameters; it returns a structured determination + obligation list + risk warnings as JSON IR. Rules sourced from NMPA UDI rules, FDA 21 CFR 830 / GUDID, and EU MDR Art 27-29 / EUDAMED.

Determination core

Rules: NMPA UDI system rules / FDA 21 CFR 830 + GUDID / EU MDR Art 27-29 + EUDAMED.
Output: JSON IR (result + rc + error_code).
Error codes: E_INPUT_MISSING / E_ENUM_INVALID / E_RUNTIME.
rc: 0 determination complete; 1 complete with warnings; 2 input insufficient/invalid.

Boundary

Rule determination only, not legal advice or certification; conclusions need human review against the regulator. Under-input triggers strict warnings (rc=1), not silent "submittable". Does not cover special cases (innovative, drug-device combos, boundary products, nanomaterials). Clause numbers are given; verify against the latest official text.

Disclaimer

AI-assisted decision support, not a registration/compliance/legal opinion. Human review; defer to the latest official documents. Text verification date 2026-09-26.

Evidence & safety

Evidence: TBD; Version: 1.0.1; Security: no independent scan (TBD).

中文

UDI 数据库提交合规判定器

何时用

UDI 码格式对了，但该传哪个库、什么时候传、必填哪些字段没人一次说清；漏传或漏维护，上市即违规。

这是什么

零依赖、确定性规则判定：传入已知条件，按公开规则源给出结构化判定+义务清单+风险提示，输出 JSON IR。规则源：NMPA UDI 规则 / FDA 21 CFR 830+GUDID / EU MDR Art 27-29+EUDAMED。

判定核心

输出 JSON IR（result+rc+error_code）；错误码 E_INPUT_MISSING/E_ENUM_INVALID/E_RUNTIME。
rc=0 判定完成；rc=1 完成带风险提示；rc=2 输入不足或非法。

能力边界

只做规则判定，不出法律意见或证明；输入不足从严提示(rc=1)；不覆盖创新器械/药械组合/边界产品/纳米材料；条款号已给出，以官方最新文本核对。

免责

AI 辅助决策支持，不构成注册/合规/法律意见；人工复核并以官方最新文件为准。

证据与安全声明

证据：TBD；版本：1.0.1；安全：未做独立安全扫描（TBD）。