维尼健康 VINNER Health · 2026-10-20 · 请结合预期用途、宣称和具体产品评估；本表不涵盖所有边界情形。
Assess the intended purpose, claims and actual product; this table does not cover every borderline case.
| 使用目的 Intended use | 主体监管框架 Primary regulatory framework | 常见分类 Common classification | 采购重点 Procurement priorities | CE CE marking |
|---|---|---|---|---|
| 身体清洁、免洗沐浴、洗发、完整皮肤日常护理Body cleansing, rinse-free bathing, hair cleansing and routine care of intact skin | Cosmetics RegulationCosmetics Regulation | CosmeticCosmetic | CPSR、PIF、CPNP、EU RP、ISO22716等CPSR, PIF, CPNP, EU Responsible Person, ISO 22716, etc. | 不适用Not applicable |
| 专门通过物理作用清洁医疗器械，隐形眼镜相关产品除外Physical cleaning specifically of medical devices, excluding contact-lens products | MDRMDR | MDR Class IMDR Class I | 分类依据、技术文件、DoC、性能资料、ISO13485等Classification rationale, technical documentation, DoC, performance evidence, ISO 13485, etc. | 需要；普通 Class I 通常无公告机构证书Required; ordinary Class I typically has no notified-body certificate |
| 非侵入性医疗器械消毒Disinfection of non-invasive medical devices | MDR Rule 16MDR Rule 16 | MDR Class IIaMDR Class IIa | 公告机构证书、DoC、消毒效力测试报告、ISO13485等Notified-body certificate, DoC, disinfectant-efficacy test reports, ISO 13485, etc. | 需要Required |
| 侵入性医疗器械处理流程终点消毒Disinfection at the endpoint of processing invasive medical devices | MDR Rule 16MDR Rule 16 | MDR Class IIbMDR Class IIb | 同上，并核实具体用途和处理流程As above; also verify the specific intended use and processing procedure | 需要Required |
| 一般人体卫生消毒，例如普通手部消毒General human-hygiene disinfection, e.g. ordinary hand disinfection | BPRBPR | BPR PT1BPR PT1 | 目标市场授权、获准用途、效力及安全性资料Target-market authorisation, authorised uses, efficacy and safety evidence | BPR本身不要求Not required by the BPR itself |
| 公共场所一般环境物表消毒Disinfection of general environmental surfaces in public places | BPRBPR | BPR PT2BPR PT2 | 同上As above | BPR本身不要求Not required by the BPR itself |
来源 / Source: VINNER Health Blog006 — “你们有 CE 证书吗？” / “Do You Have a CE Certificate?”