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udi-db-submission-check

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）。

zhaoxinghua09-cell@zhaoxinghua09-cell

Install

openclaw skills install @zhaoxinghua09-cell/udi-db-submission-check

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）。